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NCT04950296

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

Completed NA Last updated 11 July 2022
What this trial tests

NA trial testing Group I: L. plantarum UALp-05TM, in Irritable Bowel Syndrome With Diarrhea in 314 participants. Completed in 5 May 2022.

Timeline
16 September 2021
Primary endpoint
5 May 2022
5 May 2022

Quick facts

Lead sponsorVedic Lifesciences Pvt. Ltd.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeother
Enrollment314
Start date16 September 2021
Primary completion5 May 2022
Estimated completion5 May 2022
Sites12 locations across India

Drugs / interventions tested

Conditions studied

Sponsor

Vedic Lifesciences Pvt. Ltd. — full company profile →

Who can join

Adults 18 to 70, any sex, with Irritable Bowel Syndrome With Diarrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Gut Microbiome-Brain Alliance: A Landscape View into Mental and Gastrointestinal Health and Disorders.
    Sasso JM, Ammar RM, Tenchov R, Lemmel S, et al · · 2023 · cited 100× · PMID 37156006 · DOI 10.1021/acschemneuro.3c00127
  2. Efficacy and dose response of <i>Lactiplantibacillus plantarum</i> in diarrhea-predominant irritable bowel syndrome.
    Martoni CJ, Srivastava S, Damholt A, Leyer GJ. · · 2023 · cited 11× · PMID 37576702 · DOI 10.3748/wjg.v29.i28.4451

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Other Vedic Lifesciences Pvt. Ltd. trials

Trials by the same sponsor.

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