NCT03482765

A Study of Probiotics in IBS Subjects

A Double-blind Randomized, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Probiotics (UABla-12™ and DDS®-1) on Digestive Health in IBS Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• IBS

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic 1	The product under investigation is a unique probiotic.
DIETARY_SUPPLEMENT	Probiotic 2	The product under investigation is a unique probiotic.
OTHER	Placebo	Microcrystalline Cellulose

Timeline

• Start date: 2018-03-30
• Primary completion: 2019-03-14
• Completion: 2019-06-30
• First posted: 2018-03-29
• Last updated: 2019-07-05

Locations

12 sites across 1 country: India