Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) With LACTEOL® 340 mg

• Status: Terminated
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Calcium Carbonate

Criteria

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