US 20080199444A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2008/0199444 A1 Cui (43) Pub. Date: Aug. 21, 2008

(54) COMPOSITION AND METHOD FOR Publication Classification REDUCING FECESTOXINS AND TREATING (51) Int. Cl. DIGESTIVE DSORDERS A6II 35/74 (2006.01) A63L/70 (2006.01) (76) Inventor: Yunlong Cui, Shandong Province A6IPI/00 (2006.01) (52) U.S. Cl...... 424/93.41; 424/93.4; 424/93.46; (CN) 514/23 Correspondence Address: (57) ABSTRACT FSH & RICHARDSON PC This invention relates to a method of lowering feces toxin P.O. BOX 1022 levels and treating digestive disorders (e.g., Irritable Bowel Syndrome or diarrhea) with a composition containing a live MINNEAPOLIS, MN 55440-1022 beneficial bacterium, a prebiotic, or both. This method includes first identifying a subject in need thereof and then (21) Appl. No.: 11/707,607 administering to the Subject an effective amount of the com position. Also within the scope of this invention is a compo sition including both a live beneficial bacterium and a prebi (22) Filed: Feb. 16, 2007 otic. US 2008/O 199444 A1 Aug. 21, 2008

COMPOSITION AND METHOD FOR lose. The effective amount of a prebiotic can be within the REDUCING FECESTOXINS AND TREATING range of 0.7 g to 30 g per day. In particular, the effective DIGESTIVE DSORDERS amount of soy oligosaccharide orgalacto-oligosccharide is at least 10g per day; that of fructo-oligosaccharide G is at least BACKGROUND 3 g per day; and that of Xylo-oligosaccharide is at least 0.7g per day. 0001. The repellent smell of feces comes from compounds 0008. In another aspect, this invention features a method (feces toxins) such as amine, ammonia, hydrogen Sulfide, of treating a subject suffering from IBS by first identifying 3-methyl indole, indole, phenol, and thiol. Excess feces tox Such a subject and then administering to that Subject an effec ins are known to cause various medical, in particular, diges tive amount of the above-described composition. tive, conditions and diseases, in particular, digestive condi 0009. This composition can also be used to treat (1) a tions and disorders. They can act directly on intestinal and subject who suffers from diarrhea caused by eating cold or colonic walls, resulting in local inflammation or tissue dam raw food, or drinking alcohol within 24 hours, and (2) a age. The toxins also can penetrate through these walls to enter subject who suffers from both diarrhea and common cold. the blood stream, thus circulating around the whole body and 0010 Also within the scope of this invention is a compo damaging other organs. sition containing a live beneficial bacterium and a prebiotic, 0002 Irritable Bowel Syndrome (IBS) is one of the diges as well as the use of the composition for the manufacture of a tive disorders that may be associated with feces toxins. An medicament for reducing feces toxin levels and for treating IBS patient typically has abdominal discomfort, abdominal IBS and diarrhea. pain, constipation, diarrhea, or bloating. While several means 0011 Details about the live bacterium and the prebiotic may help alleviate the symptoms (e.g., exercise or intake of are described above. high fiber diet), currently there is no cure for IBS, 0012. The details of one or more embodiments of the 0003 Diarrhea is a medical condition caused by various invention are set forth in the description below. Other fea diseases (e.g., intestinal infection, intestinal inflammation, tures, objects, and advantages of the invention will be appar malabsorption, or anxiety). Some of which may be attribut ent from the description and from the claims. able to feces toxins. A diarrhea patient suffers frequent bowel evacuation or passage of abnormally soft or liquid feces. DETAILED DESCRIPTION Treatment of diarrhea depends on its causes. Traditional means to alleviate diarrhea include combined administration 0013 The present invention features a method of lowering of liquid, nutrients, and medication. the feces toxin levels in a subject in need thereof with a composition containing a live beneficial bacterium, a prebi SUMMARY otic, or a combination thereof. 0014. The levels of the repellent smell of feces are deter 0004. The present invention is based on the unexpected mined by the following standard: 0: no smell: 1-3: unpleasant; discoveries that live bacteria, such as Bacillus, Clostridium, 4-6: repellent; 7-10: highly repellent. Generally, the feces and Bifidobacterium, reduce the feces toxin levels, and that smell of a patient who needs this treatment has a level of 3 or these bacteria are effective in treating IBS and diarrhea. above. In most cases, such feces display abnormal physical 0005. In one aspect, this invention features a method of features, e.g., loose, watery, or lumpy. The Subject usually reducing the levels of feces toxins by first identifying a sub also has digestive conditions and disorders, e.g., constipation, ject in need thereof and then administering to the Subject an diarrhea, and IBS. effective amount of a composition containing a live beneficial 0015 Beneficial bacteria in the intestine and colon benefit bacterium, a prebiotic, or both. This composition can be a their host in various ways. For example, they can form on the pharmaceutical product, a food product, or a food Supple top of the intestinal and colonic walls a protective layer, ment. which blocks harmful bacteria and their toxins from damag 0006. One or more (e.g., 1-5) live beneficial bacteria, such ing or penetrating the walls. In addition, most beneficial bac as Bacillus, Clostridium, or Bifidobacterium, can be included teria secret acidic Substances (e.g., short-chain fatty acids) in this composition. For example, the composition can con resulting in an acidic environment unsuitable for the growth tain three different types of bacteria Bacillus, Clostridium, of harmful bacteria. Moreover, beneficial bacteria generate and Bifidobacterium. The Bacillus can be Bacillus subtillis, digestive enzymes to decompose food. They also promote or Bacillus coagulans (e.g. CGMCC No. 1207, deposited at digestion by secreting the just-mentioned short-chain fatty the Chinese General Microbiological Culture Collection acids, which stimulate intestine and colon movement. Center (CGMCC), Beijing, China). The Clostridium can be 0016. The term “beneficial bacterium” refers to any bac Clostridium butyricum (e.g., CGMCCNo. 0313.1.). The Bifi terium that has one or more of the features described above. dobacterium can be Bifidobacterium adolescentis, Bifidobac 0017. The live beneficial bacteria can be prepared by fer terium longum (e.g., CGMCC No. 0313.5), Bifidobacterium mentation carried out under various conditions. A bacterium bifidum (e.g., CGMCC No. 0313.7), Bifidobacterium breve can be cultured individually or co-cultured with another bac (e.g., CGMCC No. 0313.6), or Bifidobacterium infantis (e.g., terium. After the fermentation, the bacteria can be collected CGMCC No. 0313.2.). The effective amount of these benefi by centrifugation and the resultant wet pellets are then dried cial live bacteria is within the range of 10°-10'’ cfu per day. by a method that preserves the activity of the bacteria. Suit 0007 Similarly, one or more prebiotics, e.g., oligosaccha able drying methods include freeze drying, spray drying, heat rides, can be included in this composition. The oligosaccha drying, or a combination thereof. ride can be fruto-oligosaccharide G, isomalto-oligosaccha 0018. The bacteria powder thus obtained can be mixed ride, inulin, lactilol, lactosucrose, lactulose, pyrodextrin, Soy with a pharmaceutically acceptable carrier. Suitable carriers oligosaccharide, galacto-oligosaccharide, Xylo-oligosaccha include microcrystalline cellulose, mannitol, glucose, defat ride, isomalto-oligosaccharide, stachyose, raffinose or treha ted milk powder, polyvinylpyrrolidone, and starch, or a com US 2008/O 199444 A1 Aug. 21, 2008

bination thereof. The mixture of the bacteria powder and the extract (0.3%), beef exact (1%), glucose (0.5%), soluble carrier can then be presented in a variety of forms, such as starch (0.1%), sodium chloride (0.5%), anhydrous sodium tablet, capsule, or liquid. acetate (0.3%), and L-cysteine (0.05%). The bacteria were 0019. The bacteria powder also can be part of a food cultured in a shaker at 37°C. and shaken at the speed of 190 product (e.g., yogurt, milk, or Soy milk) or a food Supplement rpm for 24 hours. Then the bacteria solution was transferred (e.g., Supply nutrients or herbal products). Such food prod to a 2500 ml baffled Erlenmeyer flask containing 450 ml ucts and food Supplements can be prepared by methods well amplification media, cultured at 37° C. with shaking for known in the food industry. another 24 hours. The bacteria solution was examined under 0020 Effective amounts of the live bacterium used in this microscope for contamination. If no contamination had method can be determined based on factors such as feces occurred, the bacteria Solution was transferred into a seeding toxins levels, duration of excreting feces of a highly repellent tank containing 4.5 L amplification media and further cul Smell, age, and health condition. In general, the effective tured under aerobic conditions (air inflation amount 3:1) for amount ranges from 10° to 10" cfu per day. yet another 24 hours. The resulting bacteria solution, if not 0021. The live bacterium can be administered to a subject contaminated, was transferred to a fermentation tank filled via Suitable routes, e.g., oral administration or rectal admin with fermentation media and cultured under aerobic condi istration. It can be administered once or multiple times per tions for 24 hours. When the sporulation rate reached 80% day or administered once every several days. The treatment (determined by microscopic examination), the fermentation can last from several days to several weeks, depending on the was terminated. The bacteria were collected by centrifuging needs. at 12,000 rpm. Wet bacteria pellets were collected and 0022. Other than live bacteria, one or more prebiotics can weighed. The same amount (by weight) of defatted milk be used instead to lower feces toxin levels in a subject. Pre powder was mixed with the bacteria, dried, pulverized and biotics can selectively stimulate the growth or activity of a kept at room temperature ready for use. number of beneficial bacteria in the intestine or colon, thus indirectly inhibiting the growth of harmful bacteria. Most EXAMPLE 2 prebiotics are non-digestible oligosaccharides, e.g., fruto oligosaccharide Q isomalto-oligosaccharide, soy oligosac Effects of Live B. Coagulans and C. Butyricum on charide, galacto-oligosaccharide, or Xylo-oligosaccharide. the Levels of Amine and Ammonia in Mouse Feces They can be isolated from natural sources or prepared by and Intestines synthetic methods. Their effective amounts, generally rang 0027 Fifty ICR mice were randomly divided into five ing from 0.7 g to 30g per day, can be determined based on the groups, 10 in each group. Mice in each group were orally factors discussed above. They can be formulated and admin administered with 10 cfu B. coagulans CGMCC No. 1207, istered in the same manners as live bacteria. 10 cfu B. coagulans CGMCCNo. 1207, 10 cfu C. butyricum 0023. If necessary, one can use a composition containing CGMCC0313.1, 10 C. butyricum CGMCC0313.1, or physi both a live beneficial bacteria and a prebiotics to reduce the ological Saline, in a total volume of 0.5 ml/per mouse, once feces toxin levels in a subject in need thereof. In this embodi per day for 21 days. At day 20, mice in each group were kept ment, the effective amounts of the live bacterium and the separately in individual cages and feces from each cage were prebiotic should be at least their lowest effective amounts collected. Same amount (by weight) of feces from each cage when used individually, i.e., 10 cfu per day for a live bacte was suspended in Saline, centrifuged, and then Supernants rium and 0.7 g for a prebiotic. The bacteria and the prebiotics were collected. The amount of amine (ug/g) in each Supernant can be formulated separately or together. In the former situ sample was determined, using the neutralization method ation, they can be administered simultaneously or sequen described in WANG et al., Chinese Journal of Microecology, tially. 2006,18(1):6-8) 0024. The composition described above can also be used 0028. The treated mice were sacrificed at day 21, their to treat IBS and diarrhea, which is caused by eating cold/ appendix excised and weighed. Same amount of the appendix frozen or raw food or drinking alcohol within 24 hours, or is from each mouse was then grounded and Suspended in physi associated with common cold. ological saline. After centrifugation, the Supernants were col 0025. The specific examples below are to be construed as lected and the amount of ammonia contained therein was merely illustrative, and not limitative of the remainder of the quantified (ug/g) following the method described in YINet disclosure in any way whatsoever. Without further elabora al., Chinese Journal of Microecology, 2003, 15(4):212. tion, it is believed that one skilled in the art can, based on the (0029. Both B. coagulans CMGCCNo. 1207 and C. butyri description herein, utilize the present invention to its fullest cum CGMCC0313.1 reduced the quantities of amine and extent. All publications cited herein are hereby incorporated ammonia in mouse feces and intestines at both dosages, by reference in their entirety. respectively. Statistical analysis using Analysis of Variance (ANOVA) showed that the reductions were significant (P<0. EXAMPLE1 05), compared to control mice (treated with saline). Preparation of Bacteria Powder Containing Live EXAMPLE 3 Clostriduim Butyricum Effects of B. Coagulans and C. Butyricum on the 0026 Clostriduim butyricum CGMCC No. 0313.1 stored Levels of Indole and 3-Methyl-Indole in Human in a tube was suspended in a 100 ml autoclaved Erlenmeyer Feces flask containing 10 ml physiological saline and Suitable amount of glass beads. After 10 minutes, 1 ml bacteria solu 0030 Sixteen volunteers (six male and ten female, age tion was inoculated into a 250 ml Erlenmeyer flask filled with 25-55) were randomly divided into two groups, one taking 50 ml amplification media containing tryptone (1%), yeast tablets containing live B. coagulans CMGCC No. 1207 and US 2008/O 199444 A1 Aug. 21, 2008 the other capsules containing live C. butyricum CMGCCNo. 03.13.1. The amount of the live bacterium contained in each TABLE 1 tablet is 1.75x10" cfu and in each capsule is 0.42x10 cfu. Each volunteer took three B. coagulans tablets or three C. Physical features of normal and abnormal feces: butyricum capsules after each meal, three times per day, for Normal Abnormal 14 days. During this period, all Volunteers maintained their Color yellow, yellowish brown dark brown, black or grey regular diets. Feces were collected before and after taking the or yellowish green tablets or capsules and the levels of indole and 3-methyl Shape/hardness Soft or slightly solid, hard, lumpy, loose or indole contained therein were quantified using HP-6890 banana-shaped watery HPLC. Repellent smell* Levels 0–2 Levels 3 and above 0031 Half gram (0.5 g) fresh feces were suspended in 20 ml ethanol and extracted by ultrasound for 20 minutes. The *See standard described above. solutions were then filtered, added with 3 ml 0.1% p-Isopro pylphenol as an internal control, and diluted to 25 ml in a EXAMPLE 5 25-ml volumetric flask. Four microliters (4 ul) of the above Solution were injected into a chromatography column (HP Joint Effects of B. Coagulans and Xylo-Oligosaccha INNO WAX glass capillary, 30 mx0.53 mm, filled with 17% rides on the Physical Features of Human Feces silicone SE-30) and analyzed under the following conditions: column temperature: 200° C.; Sample injection system tem 0035 Sixty volunteers (30 male and 30 female, age perature: 230°C.; detector temperature: 260°C., N, flow rate: 20-50), who had maintained their regular diets, were taken 3 90 ml/min: He flow rate: 58 ml/min: air flow rate: 60 ml/min. tablets containing both live B. coagulans CMGCC No. 1207 0032. Both the B. coagulans tablets and the C. butyricum and Xylo-oligosaccharide, after each meal, three times per capsules significantly reduced the levels of indole and 3-me day, for seven days. Each tablet contains at least 0.35x10" cfu thyl-indole contained in the volunteers feces. Statistical live bacteria and at least 0.10 g Xylo-oligosaccharide. During analysis showed that these reductions are significant. this period, physical features of their feces as described above EXAMPLE 4 were observed immediately after every bowel movement. 0036) Feces of all 60 volunteers displayed one or more Effects of B. coagulans on Physical Features of abnormal physical features before taking the tablets. Some of Human Feces and Symptoms of Digestive Disorders the Volunteers also showed symptoms of digestive disorders, 0033 Forty-two volunteers (20 male and 22 female, age Such as constipation, loss of appetite, bellyache, and borbo 20-30) were taken tablets containing live B. coagulans rygmus. After treatment, most volunteers showed signifi CMGCC No. 1207 (at least 0.35x107 cfu per tablet), 3 tablets cantly reduced abnormal features of their feces. Their symp after each meal, three times per day, for seven days. All toms of digestive tract disorders were also alleviated. Volunteers had maintained their regular diets in this period. Physical features of their feces, such as odor, shape, and color, EXAMPLE 6 were observed immediately after every bowel movement. The normal and abnormal physical features of feces are Summa Effects of Live C. Butyricum in Treating Irritable rized in Table 1. Bowel Syndrome (IBS) 0034) Feces of all 42 volunteers displayed one or more abnormal physical features before taking the B. coagulans 0037 Fifty IBS patients, diagnosed according to the tablets. Some Volunteers also showed symptoms of digestive Roman II standards described in Table 2, were treated with disorders, such as constipation, loss of appetite, bellyache, capsules containing C. butyricum CGMCC No. 0313.1, three and borborygmus. After treatment, most Volunteers showed capsules each time, twice a day, for 14 to 21 days. Each significantly reduced abnormal features of their feces. These capsule contains at least 10x10 cfu/g live bacteria. During Volunteers also had alleviated symptoms of digestive disor this period, these patients were observed for IBS symptoms, ders. e.g., abdominal pain, constipation, or diarrhea.

TABLE 2

Roman II Standards: Degree of Stool Passage - Straining, Degree of incomplete, or Degree of Pain while Degree of Pain Bloating Urgent Borborygmus pressing abdomen No Pain O No. O No O Normal O No. Slight, does 1 Rare 1 Rare 1 active 1 Slight 1 not affect daily activity Intermediate 2 Occasional 2 Occasional 2 slightly 2 Pain 2 pain, affect hyperactive daily activities, need medication Aug. 21, 2008

TABLE 2-continued

Roman II Standards: Degree of Stool Passage - Straining, Degree of incomplete, or Degree of Pain while Degree of Pain Bloating Urgent Borborygmus pressing abdomen Severe pain, 3 Frequent 3 Frequent 3 Hyperactive 3 Severe pain 3 affect daily activities, need medication and rest

0038 Standards of efficacy are described below: abdominal pain, constipation, or diarrhea. The efficacy of this 0039. Cured: Patients feces display normal physical fea treatment was determined according to the above-described tures. Patients have normal numbers of bowel movement standards. every day, i.e., 1-2 times, with yellow, shaped feces. No other 0045 All of the IBS patients showed one or more IBS IBS symptoms. symptoms before treatment. After taking the B. Coagulans 0040. Effective: Patients have obviously improved physi tablets, most of these patients had ameliorated symptoms of cal features of their feces and obviously alleviated IBS symp diarrhea or constipation. Other IBS symptoms, such as toms, e.g., 2-3 times bowel movement per day or >3 times per abdominal pain and discomfort were also alleviated in these week, with yellow, soft feces. patients. The efficacy of treating IBS with B. Coagulans 0041 Improved: Patients have improved physical features tablets are shown in Table 4. The rate of complete recovery of their feces and alleviated IBS symptoms, e.g., 3 times (cured) was 65% (30/65) and the overall effective rate was bowel movement per day, or 3 times per week, with yellow, 93% (43/46). No side effects were observed during this treat loose feces. ment. 0042. Ineffective: Patients have no improvement as to physical features of their feces and other IBS symptoms. TABLE 4 0043 All of the IBS patients showed one or more IBS symptoms before treatment. After taking the C. butyricum Efficacy of treating IBS with B. Coagularis Tablets capsules for averagely two days, symptoms of diarrhea or Effective constipation started ameliorating. Other IBS symptoms. Such Cured Effective Improved Ineffective Cases as abdominal pain and discomfort were also alleviated in these patients. The rate of complete recovery (cured) was Case Case Case Case Case Case 62% (31/50) and the overall effective rate was 94% (47/50), No. No. 9% No. % No. % No. % No. 9% see Table 3. No side effects were observed during this treat 46 3O 65 13 28 3 7 O O 43 93 ment.

TABLE 3 EXAMPLE 8 Efficacy of treating IBS with live C. butyricum Effects of Live Bifidobacterium on IBS Effective Cured Effective Improved Ineffective Cases 0046 Fifty-seven IBS patients (male 35, female 22, aver Case Case Case Case Case Case age age 40.5+10.8) were participated in this study. These No. No. 9% No. % No. % No. % No. 9% patients had IBS symptoms for 20.5 months in average. Among them, 38 patients had diarrhea, 9 constipation, and 10 50 31 62 16 32 3 6 O O 47 94 both. They were orally administered with tablets containing live Bifidobacterium infantis CGMCCNo.0313.2, three tab lets each time, three times a day, for 14 to 21 days. Each tablet EXAMPLE 7 contains at least 1.0x10 cfu/g live bacteria. During this period, patients were observed for IBS symptoms, e.g., Effects of Live B. Coagulans in Treating IBS abdominal pain, constipation, or diarrhea. The efficacy stan 0044) Forty-six IBS patients (male 29, female 17, average dards are the same as described above. age 43.5+11.9) were participated in this study. These patients 0047. After taking the Bifidobacterium tablets, most of had IBS symptoms for 22.9 months in average. Among them, these patients had ameliorated symptoms of diarrhea or con 30 patients had diarrhea, 6 constipation, and 10 both diarrhea stipation. Other IBS symptoms, such as abdominal pain and and constipation. They were orally administered with tablets discomfort, were also alleviated in these patients. The effi containing live B. Coagulans CGMCC No. 1207, three tab cacy of treating IBS with the Bifidobacterium tablets are lets each time, three times a day, for 14 to 21 days. Each tablet shown in Table 5. The rate of complete recovery (cured) was contains at least 1.0x10 cfu/g live bacteria. During this 61% (35/57) and the overall effective rate was 89% (51/57). period, these patients were observed for IBS symptoms, e.g., No side effects were observed during this treatment. US 2008/O 199444 A1 Aug. 21, 2008

EXAMPLE 10 TABLE 5 Effects of Bacillus, Clostridium, and Bifidobacte Efficacy of treating IBS with live Bifidobacterium rium in Treating Diarrhea Associated with Alcohol Effective Intake Cured Effective Improved Ineffective Cases

Case Case Case Case Case Case 0051 One hundred and fourteen patients (male 100, No. No. 9% No. % No. % No. % No. 9% female 14, age 18-70, average age 40) were selected for this study. All of them showed one of the following symptoms 57 3S 61 16 28 6 11 O O S1 89 within 24 hours after drinking alcohol: (1) abdominal pain or discomfort coupled with frequent bowel movement (>3 times per 24 hours), (2) abdominal pain or discomfort coupled with EXAMPLE 9 changes in physical features of feces (loose, watery etc.), and (3) diarrhea that has been lasted for 2 weeks to 2 months. Effects of Live Bacillus, Clostridium, and Bifodo 0.052 These patients were orally administered with cap bacterium in Treating Diarrhea Associated with Cold sules containing live C. butyricum CGMCCNo.0313.1 (420 or Raw Food, or with Common Cold mg per capsule), tablets containing live B. coagulans CGM CCNo. 1207 (350 mg per tablet), or Bifidobacterium infantis 0048 One hundred and twenty-seven patients (male 79, CGMCCNo.0313.2 (350 mg per tablet), three capsules/tab female 48, age 18-70, average age 39) were selected for this lets each time, three times per day, for 14 to 21 days. In each study. All of them showed one of the following symptoms capsule or tablet, the amount of the live bacterium is at least within 24 hours after eating cold/raw food, or developing a 10x10 cfu/g. Symptoms such as frequency of bowel move common cold: (1) abdominal pain or discomfort coupled with ment, physical features of feces, abdominal pain and discom frequent bowel movement (>3 times per 24 hours), (2) fort, bloating, or borborygmus were observed immediately abdominal pain or discomfort coupled with changes in physi after termination of the treatment. The standards to determine cal features of feces (loose, watery etc.), and (3) diarrhea that efficacy is the same as described above. has been lasted for 2 weeks to 2 months. 0053 Live bacteria of C. butyricum, B. coagulans, and Bifidobacterium are highly effective in treating diarrhea asso 0049. These patients were orally administered with cap ciated with alcohol intake. Patients treated with these live sules containing live C. butyricum CGMCCNo.0313.1 (420 bacteria had significantly reduced numbers of bowel move mg per capsule), tablets containing live B. coagulans CGM ment per day after the treatment. In addition, most of the CCNo. 1207 (350 mg per tablet), or Bifidobacterium infantis patients had improved physical features of their feces and CGMCCNo.0313.2 (350 mg per tablet), three capsules/tab reduced abnormal bowel movement. Other symptoms, such lets each time, three times per day, for 14 to 21 days. In each as abdominal pain, bloating, and borborygmus, were also capsule or tablet, the amount of live bacteria is at least 1.0x alleviated in these patients. The overall efficacy of this treat 10° cfu/g. Symptoms such as frequency of bowel movement, ment is summarized in Table 7. physical features of feces, abdominal pain and discomfort, bloating, or borborygmus, were observed immediately after TABLE 7 termination of the treatment. The standards to determine effi Efficacy of live C. butyricum, B. coagulans, and Bifidobacterium cacy are the same as described above. on diarrhea associated with common cold 0050 Live bacteria of C. butyricum, B. coagulans, and Bifidobacterium are highly effective in treating diarrhea asso Case Effec- Im- Inef ciated with eating cold or raw foods, or with common cold. Bacterium Used No. Cured tive proved fective Efficacy These patients had significantly reduced numbers of bowel C. butyricum 35 2O 11 4 O 88.6% movement per day after taking the tablets or capsules. In B. coagulans 41 27 9 5 O 87.8% addition, most of the patients had improved physical features Bifidobacterium 38 21 13 4 O 89.5% of their feces and reduced abnormal bowel movement after taking these drugs. Other symptoms, such as abdominal pain, bloating, and borborygmus, were also alleviated in these Other Embodiments patients. The overall efficacy of this treatment is summarized in Table 6. 0054 All of the features disclosed in this specification may be combined in any combination. Each feature disclosed in this specification may be replaced by an alternative feature TABLE 6 serving the same, equivalent, or similar purpose. Thus, unless Efficacy of live C. butyricum, B. coagulans, expressly stated otherwise, each feature disclosed is only an and Bifidobacteriurn on diarrhea example of a generic series of equivalent or similar features. Case Effec- Im- Inef 0055 From the above description, one skilled in the art Bacterium Used No. Cured tive proved fective Efficacy can easily ascertain the essential characteristics of the present invention, and without departing from the spirit and scope C. butyricum 45 26 15 4 O 91.10% B. coagulans 40 25 12 3 O 92.50% thereof, can make various changes and modifications of the Bifidobacterium 42 23 14 5 O 88.10% invention to adapt it to various usages and conditions. Thus, other embodiments are also within the scope of the following claims. US 2008/O 199444 A1 Aug. 21, 2008

1. A method for lowering the levels of feces toxins, com 21. The composition of claim 20, wherein the beneficial prising bacterium is a Bacillus, a Clostridium, or a Bifidobacterium. identifying a subject in need thereof, and 22. The composition of claim 21, wherein the Bacillus is administering to the Subject an effective amount of a com Bacillus coagulans, or Bacillus subtitis. position containing a live beneficial bacterium, a prebi 23. The composition of claim 22, wherein the Bacillus is otic, or both. Bacillus coagulans CGMCC No. 1207. 2. The method of claim 1, wherein the beneficial bacterium 24. The composition of claim 21, wherein the Clostridium is a Bacillus, a Clostridium, or a Bifidobacterium. is Clostridium butyricum. 3. The method of claim 2, wherein the Bacillus is Bacillus 25. The composition of claim 24, wherein the Clostridium coagulans, or Bacillus subtilis. butyricum is Clostridium butyricum CGMCC0313.1. 4. The method of claim 3, wherein the Bacillus is Bacillus 26. The composition of claim 21, wherein the Bifidobac coagulans CGMCC No. 1207. terium is Bifidobacterium adolescentis, Bifidobacterium lon 5. The method of claim 2, wherein the Clostridium is gum, Bifidobacterium bifidum, Bifidobacterium infantis or Clostridium butyricum. Bifidobacterium breve. 6. The method of claim 5, wherein the Clostridium butyri 27. The composition of claim 26, wherein Bifidobacterium cum is Clostridium butyricum CGMCC No. 0313.1. is Bifidobacterium longum CGMCC No. 0313.5, Bifidobac 7. The method of claim 2, wherein the Bifidobacterium is terium bifidum CGMCC No. 0313.7, Bifidobacterium infan Bifidobacterium adolescentis, Bifidobacterium longum, Bifi tis CGMCC No. 0313.2 or Bifidobacterium breve CGMCC dobacterium bifidum, Bifidobacterium infantis or Bifidobac No. 03136. terium breve. 28. The composition of claim 18, wherein the composition 8. The method of claim 7, wherein the Bifidobacterium is comprises 1-5 live beneficial bacteria. Bifidobacterium longum CGMCC No. 0313.5, Bifidobacte 29. The composition of claim 18, wherein the prebiotic is rium bifidum CGMCC No. 0313.7, Bifidobacterium infantis oligosaccharide. CGMCC No. 0313.2 or Bifidobacterium breve CGMCC No. 30. The composition of claim 28, wherein the oligosaccha O3136. ride is fructo-oligosaccharide, isomalto-oligosaccharide, inu 9. The method of claim 1, wherein the effective amount of lin, lactilol, lactosucrose, lactulose, pyrodextrin, Soy oli the beneficial bacterium is about 10°-10" cfu per day. gosaccharide, galacto-oligosaccharide, O Xylo 10. The method of claim 1, wherein the composition con oligosaccharide. tains 1-5 live beneficial bacteria. 31. The composition of claim 18, wherein the composition 11. The method of claim 1, wherein the prebiotic is oli comprises more than one prebiotics. gosaccharide. 32. The composition of claim 18, wherein the composition 12. The method of claim 11, wherein the oligosaccharide is is a pharmaceutical product, a food product, or a food Supple fructo-oligosaccharide, isomalto-oligosaccharide, inulin, ment. lactilol, lactosucrose, lactulose, pyrodextrin, soy oligosac 33. The composition of claim 32, wherein the composition charide, galacto-oligosaccharide, or Xylo-oligosaccharide. further is a pharmaceutical product. 13. The method of claim 11, wherein the oligosaccharide is 34. A method for treating irritable bowel syndrome, com Soy oligosaccharide and the effective amount thereof is at prising least 10 g per day. identifying a Subject in need thereof, and 14. The method of claim 11, wherein the oligosaccharide is administering to the Subject an effective amount of a com galacto-oligosaccharide and the effective amount thereof is at position containing a live beneficial bacterium, a prebi least 10 g per day. otic, or a combination thereof. 15. The method of claim 11, wherein the oligosaccharide is 35. A method for treating diarrhea, comprising fructo-oligosaccharide G and the effective amount thereof is identifying a subject suffering from diarrhea that starts at least 3 g per day. within 24 hours after the subject eats cold or raw food, or 16. The method of claim 11, wherein the oligosaccharide is drinks alcohol, and Xylo-oligosaccharide and the effective amount thereof is at administering to the Subject an effective amount of a com least 0.7 g per day. position containing a live beneficial bacterium, a prebi 17. The method of claim 1, wherein the composition con otic, or a combination thereof. tains more than one prebiotics. 36. A method for treating diarrhea, comprising 18. The method of claim 1, wherein the composition is a identifying a diarrhea Subject who also suffers from com pharmaceutical product, food product, or food Supplement. mon cold, and administering to the Subject an effective 19. The method of claim 18, wherein the composition amount of a composition containing a live beneficial further is a pharmaceutically product. bacterium of, a prebiotic, or a combination thereof. 20. A composition comprising a live beneficial bacterium and a prebiotic. c c c c c