Study to Determine Efficacy of Probiotics in Irritable Bowel Syndrome

• Status: Withdrawn
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Irritable bowel syndrome (IBS) is the most common functional GI disorder in which abdominal pain and/or discomfort is associated with changes in bowel habit, and with features of disordered defecation. IBS affects 10-20% of the population and causes a marked reduction of quality of life in affected individuals.The high prevalence of IBS is accompanied by large societal economic burdens and negative effects on the quality of life in affected patients. It is divided into 3 types IBS-D diarrhea predominant, IBS-C constipation predominant, IBS-M mixed sub type.

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

Details

• Lead Sponsor: Next Gen Pharma India Pvt. Ltd.
• Collaborator: Department of Gastroenterology, Govt. Medical College, Kozhikode, Kerala, India

Criteria

Inclusion Criteria:

1. Positive diagnoses of IBS subtype IBS-D defined by Rome III criteria, and who meet the following criteria:

a) Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) b) abdominal pain score of > 3.0 on a 0 to 10 point scale & c) Stool Consistency of at least one stool with a consistency of Type 6 or Type 7 Bristol stool score (BSS) on at least 2 days per week

2. Signed informed consent

Exclusion Criteria:

1. Patients currently using non-steroidal anti-inflammatory drugs, corticosteroids and mast cell stabilizers, or topical or systemic antibiotics in the past 1 month.

2. Patients with major abdominal surgery, a history of inflammatory bowel disease or diverticular disease, celiac disease (by detection of anti-transglutaminase and anti-endomysial antibodies), allergic diseases, including asthma (excluded by family and personal history and specific anti-IgE antibodies), and other organic or psychiatric disorders as assessed by medical history, appropriate consultations and laboratory tests.

3. Females who are Pregnant, breast-feeding, or not using reliable methods of contraception