NCT04950296

To Study the Efficacy and Safety of L. Plantarum UALp-05TM in Diarrhea- Predominant-irritable Bowel Syndrome

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of L. Plantarum UALp-05TM in Diarrhea- Predominant-irritable Bowel Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Several probiotic strains have shown beneficial outcomes in IBS patients, particularly among the Lactobacillus and Bifidobacterium genera, Lactobacillus plantarum (recently reclassified as Lactiplantibacillus plantarum) is a frequently isolated species of the healthy human GI tract that has been studied in numerous GI clinical studies, including for IBS.In the present study, the efficacy and tolerability of L. plantarum (UALp-05TM), will be evaluated in individuals with IBS-D.

Detailed description

Several strains of Lactobacillus genus have previously been assessed in patients with IBS in multiple randomized controlled trials, demonstrating the efficacy of these strains in reducing IBS-related symptoms such as abdominal pain, distension and flatulence. We hypothesize the L. plantarum UALp-05 strain to benefit research participants by reducing pain severity, normalizing diarrhea predominant stool type and subsequently improving quality of life (QOL) standards. The current study with L. plantarum UALp-05, will include a lower dose of 1 billion CFU/day (considered a low dose among probiotic IBS studies) and a higher dose of 10 billion CFU/ day (considered a mid-point dose among probiotic IBS studies) for a period of 8-weeks.Each probiotic dosage group will be assessed individually in comparison to placebo.

Conditions

• Irritable Bowel Syndrome With Diarrhea

Interventions

Type	Name	Description
OTHER	Group I: L. plantarum UALp-05TM,	One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.
OTHER	Group II: L. plantarum UALp-05TM,	One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.
OTHER	Microcrystalline cellulose	One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.

Timeline

• Start date: 2021-09-16
• Primary completion: 2022-05-05
• Completion: 2022-05-05
• First posted: 2021-07-06
• Last updated: 2022-07-11

Locations

12 sites across 1 country: India