Randomized,Double-blind, Placebo Controlled Trial to Study the Efficacy and Safety of Probiotics in Adult Patients With Irritable Bowel Syndrome-diarrhea Predominant (IBS-D)

NCT02545413 Phase 3 WITHDRAWN

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.

Details

Lead sponsor	Next Gen Pharma India Pvt. Ltd.
Phase	Phase 3
Status	WITHDRAWN
Start date	2016-05
Completion	2017-12

Conditions

• Irritable Bowel Syndrome

Interventions

• Probiotic VSL#3
• Placebo

Primary outcomes

• Comparison of the intensity of abdominal pain relief and change in stool consistency before and after treatment, between the two arms — 8 wks (after end of treatment)
  The defecation component of the primary endpoint will be evaluated by assessing stool consistency as per "Bristol Stool Form Scale". Abdominal pain component of primary end point will be accessed by using an 11-point (i.e., 0 to 10) numeric rating scale that asks patients daily to rate their worst abdominal pain over the past 24-hours

Countries

India