Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) With LACTEOL® 340 mg
Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) With LACTEOL® 340 mg
Irritable bowel syndrome is a complex condition with a high unmet medical need for effective
 and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and
 symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a
 potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).
This study will include the following phases: Screening Phase, Run-In Phase, Double-Blind
 Treatment Phase and Open-Label Treatment Phase.

 Screening: Eligibility of subjects will be evaluated following informed consent signature.
 Screening procedures/evaluations (physical exam, concomitant medications, clinical laboratory
 tests) and confirmation of eligibility following Rome III Diagnostic questionnaire will be
 performed.

 Run-In: Subjects will enter a 2-week Run-In Phase during which IBS Symptoms and Stool
 Characteristics will be recorded. At the end of the Run-In Phase, data collected over the
 last week will be reviewed. Upon confirmation of IBS-D severity status, subjects may be
 randomized.

 Double-Blind Treatment: Subjects will take study medication (either LACTEOL® 340 mg or
 Placebo) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global
 assessment of relief will be recorded, and clinical laboratory tests will be performed. HAD
 score will be assessed at the end of the double blind treatment.

 Open-Label Treatment: All study completers will be eligible for a second 28 day Open-Label
 Treatment in the event that IBS-D symptoms remain or recur within the month following the end
 of Double-Blind Treatment. Subjects will take the study medication (LACTEOL® 340 mg) for 28
 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of
 relief will be recorded, and clinical laboratory tests will be performed.
Inclusion Criteria:

 -  IBS-D diagnosis using the Rome III questionnaire

 -  IBS Symptoms Severity Scale (IBS-SSS) score ranging between 100 and 400

 -  Bristol Stool Form Scale score exceeding two (> 2) but less than seven (< 7)

 -  Stable diet

 -  Mental and legal ability to sign informed consent

 Exclusion Criteria:

 -  Diagnosis of Inflammatory Bowel Disease (IBD)

 -  Chronic use of systemic steroids

 -  Diagnosis of autoimmune Diseases or Disorders

 -  Invasive abdominal surgery

 -  Use of antibiotics prior to screening

 -  Allergy to active substance or any other ingredient in LACTEOL® 340 mg

 -  Congenital galactosemia, glucose, fructose and/or galactose malabsorption syndrome,
 lactase deficiency or lactose intolerance

 -  Diagnosis of exocrine pancreatic insufficiency

 -  Use of any experimental drug within the 30 days prior to screening