Last reviewed · How we verify
NCT04950296
To Study the Efficacy and Safety of L. Plantarum UALp-05TM in Diarrhea- Predominant-irritable Bowel Syndrome
NA trial testing Group I: L. plantarum UALp-05TM, in Irritable Bowel Syndrome With Diarrhea in 314 participants. Completed in 5 May 2022.
5 May 2022
Quick facts
| Lead sponsor | Vedic Lifesciences Pvt. Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 314 |
| Start date | 16 September 2021 |
| Primary completion | 5 May 2022 |
| Estimated completion | 5 May 2022 |
| Sites | 12 locations across India |
Drugs / interventions tested
- Group I: L. plantarum UALp-05TM,
- Group II: L. plantarum UALp-05TM,
- Microcrystalline cellulose — full drug profile →
Conditions studied
- Irritable Bowel Syndrome With Diarrhea — all drugs for Irritable Bowel Syndrome With Diarrhea →
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):
-
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 -
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
Verify or expand the search:
- PubMed search for NCT04950296
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Vedic Lifesciences Pvt. Ltd. trials
Trials by the same sponsor.
- NCT07141368 — Single Oral Dose Comparative Bioavailability Study of Investigational Product in Healthy Human Subjects Under Fasting Co · NA · not yet recruiting
- NCT07033754 — A Study to Assess the Effect Probiotic Supplement on Immune Health in Teachers Prone to Upper Respiratory Tract Infectio · NA · not yet recruiting
- NCT06917287 — A Clinical Study to Evaluate the Efficacy of Native CT-II® in Individuals With Knee Osteoarthritis · NA · recruiting
- NCT06859346 — A Clinical Study to Assess the Effect of Tisina Complex on Cognitive Health in Individuals With Mild Cognitive Impairmen · NA · completed
- NCT06473246 — A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants. · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04950296 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vedic Lifesciences Pvt. Ltd.
- Last refreshed: 11 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04950296.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing