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Clinical Trial Summary

For the current study, the primary outcome is to evaluate the effect of IP on abdominal pain.

The secondary outcome is to assess the effect of IP on IBS-Symptom Severity, IBS-related quality of life, stool form and consistency and on mental status.

Thus providing an effective objective in improving the gut health and symptomatic relief in IBS patients.


Clinical Trial Description

This study aims to determine the effect of probiotics, as the investigational products (IPs) in subjects satisfying the Rome IV criteria for IBS. Three hundred and sixty six subjects between 18 to 70 years of age and with a positive diagnosis of Rome IV IBS criteria (IBS-C, D, M and U types) and moderate to severe abdominal pain intensity will be recruited in a multi-center, double-blind, parallel group, placebo-controlled randomized trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03482765
Study type Interventional
Source Vedic Lifesciences Pvt. Ltd.
Contact
Status Completed
Phase N/A
Start date March 30, 2018
Completion date June 30, 2019

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