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Study to Determine Efficacy of Probiotics in Irritable Bowel Syndrome

NCT02545413 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-03-23

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Probiotic VSL#3

DRUG

Placebo

Sponsors & Collaborators

  • Department of Gastroenterology, Govt. Medical College, Kozhikode, Kerala, India

    collaborator UNKNOWN

  • Next Gen Pharma India Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Shejal A Hanmant, DM Trainee · Government Medical College, Kozhikide, Kerala, India

  • Varghese Thomas, DM · Government Medical College, Kozhikide, Kerala, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-06-30
Completion
2017-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02545413 on ClinicalTrials.gov