Efficacy of Probiotic Bacteria in Subjects With IBS or Functional Diarrhea/ Bloating
Efficacy of Probiotic Bacteria in Subjects With IBS or Functional Diarrhea/ Bloating
To determine if probiotics bacteria, specifically lactobacillus and bifidobacterium, improve
 gastrointestinal symptoms in patients with IBS, functional diarrhea, or functional bloating.
Functional Bowel disorders (FBD) including Irritable Bowel Syndrome (IBS) are characterized
 by a variable combination of chronic or recurrent gastrointestinal symptoms not explained by
 structural or biochemical abnormalities. IBS is the most common functional gastrointestinal
 disorder, affecting 8% to 23% of adults in the western world and accounts for 12% of primary
 care and 28% of gastroenterological practice visits yearly. The pathophysiology of IBS is not
 completely understood and currently available drug treatments for IBS are very limited (1-2).
 The apparent success of the use of probiotics in several gut disorders (e.g., IBD) together
 with the greater understanding of the role of inflammation and intestinal microflora in the
 pathophysiology of IBS has led to increased interest in use of probiotics in patients with
 IBS (3). The data on the use of probiotic in IBS is limited. However, few reported studies
 show encouraging results and suggests some symptomatic response and parallel improvement in
 quality of life (3-4). A controlled, double-blind study, randomized 20 patients with IBS to
 L. plantarum 299v or placebo for 4 weeks concluded that L. plantarum decreased abdominal pain
 and tended to normalize stool frequency in constipated patients (5). On the other hand,
 Lactobacillus casei GG, was found to improve stool consistency in patients with IBS and
 diarrhea (6). A recent randomized controlled trial using the probiotic formulation VSL#3
 improved abdominal bloating in patients with diarrhea-predominant IBS. However, no
 differences in gastrointestinal transit measurement, bowel function scores or satisfactory
 global symptom relief were shown (7). The inconsistent findings of these clinical studies may
 be accounted to the differences in probiotics composition and the heterogeneous and
 multifactorial nature of the disorder. However, these studies indicate a potential
 relationship between probiotics therapy and functional abdominal symptoms and suggesting that
 the possible role of probiotics in the treatment of IBS deserves further study.
Inclusion Criteria:

 -  The subject is 18 to 75 years old.

 -  The subject is an ambulatory outpatient.

 -  The subject has IBS, or functional diarrhea, or functional bloating according to the
 Rome II criteria for functional GI disorders.

 -  The subject has the above symptoms for at least two weeks, despite current therapy.
 For diarrhea, we will use the definition of a mean of >2 bowel movements per day, or a
 mean score of > 4 on the Bristol Stool Form Scale per week. For bloating we will use
 the Rome II definition "a feeling of abdominal fullness or bloating".

 -  Subject must have had a colonoscopy if age > 50y/o.

 -  The subject's symptoms are mild to moderate symptoms in severity. Symptoms severity
 will be assessed at baseline and at the end of the 2-weeks screening period to
 determine eligibility prior randomization. Severity of bowel symptoms will be
 determined using the Francis Whorwell IBS severity scale: Mild <175, Moderate 175-300,
 Severe >300

 Exclusion Criteria:

 -  The subject has inflammation or structural abnormality of the digestive tract (e.g.
 inflammatory bowel disease (IBD), duodenal ulcer (DU) or gastric ulcer (GU),
 obstruction, symptomatic cholelithiasis).

 -  The subject has severe FBD related symptoms at baseline.

 -  The subject has a serious, unstable medical condition.

 -  The subject has insulin-dependent Diabetes Mellitus.

 -  The subject had a major psychiatric diagnosis or a suicide attempt within the last two
 years.

 -  The subject has a history of alcohol or substance abuse within two years.

 -  The subject has abnormal laboratory results (including ALT or AST > than 2.5 times
 normal, serum creatinine >2.0mg/dl, untreated abnormal TSH value)

 -  The subject has been treated for a malignancy within the last 5 years (except BCC or
 SCC skin cancer).

 -  The subject has been diagnosed with lactase deficiency and this can explain their
 symptoms (i.e., symptoms resolved or reduced significantly with lactose-free diet.)

 -  The subject has participated in a drug study within the last 21 days.

 -  The subject received antibiotic treatment during the last 8 weeks. (If the subject was
 on antibiotic treatment, a washout period of 8 weeks is required).

 -  The subject had previous significant intestinal surgery.

 -  The subject is pregnant or lactating, or unwilling to maintain effective contraception
 during course of study

 -  The subject is predisposed to infection (i.e. their immune system is compromised, they
 have rheumatic heart disease, an artificial valve, history of bacterial endocarditis,
 or an active bacterial disease)