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

NCT04950296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2022-07-11

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome With Diarrhea

Interventions

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.

Sponsors & Collaborators

  • Vedic Lifesciences Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Ramesh Dargad · Stress test clinic

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2022-05-05
Completion
2022-05-05

Countries

  • India

Study Locations

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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 NCT04950296 on ClinicalTrials.gov