Who is sponsoring NCT02728063?

NCT02728063 is sponsored by PiLeJe.

What drugs are being tested in NCT02728063?

Interventions in NCT02728063: Lactibiane Tolerance.

What condition does NCT02728063 study?

NCT02728063 studies Diarrhea Predominant Irritable Bowel Syndrome.

Is NCT02728063 still recruiting?

NCT02728063 is currently completed. Last updated 23 February 2021.

Last reviewed 2021-02-23 · How we verify

NCT02728063: PILATE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Lactibiane Tolérance® in Individuals Suffering From Irritable Bowel Syndrome With Diarrheal Predominance

Completed NA Last updated 23 February 2021

What this trial tests

NA trial testing Lactibiane Tolerance in Diarrhea Predominant Irritable Bowel Syndrome in 30 participants. Completed in 11 April 2018.

Timeline

11 May 2016

Primary endpoint
11 April 2018

11 April 2018

Quick facts

Lead sponsor	PiLeJe
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	11 May 2016
Primary completion	11 April 2018
Estimated completion	11 April 2018
Sites	1 location across France

Drugs / interventions tested

Lactibiane Tolerance

Conditions studied

Diarrhea Predominant Irritable Bowel Syndrome — all drugs for Diarrhea Predominant Irritable Bowel Syndrome →

Sponsor

PiLeJe — full company profile →

Who can join

Adults 18 to 75, any sex, with Diarrhea Predominant Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main objective of the study is to evaluate the effect on intestinal permeability of a supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from irritable bowel syndrome (IBS) with diarrhea predominance. Secondary objectives of the study are to evaluate the effects of supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from IBS with diarrhea predominance on intestinal permeability, inflammation of the digestive tract, symptoms and comfort. Single-center study in single open arms: 30 volunteer adults suffering from Irritable Bowel Syndrome (IBS) with diarrhea predominance and matching the criteria of inclusion and non-inclusion listed below.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Could the Microbiota Be a Predictive Factor for the Clinical Response to Probiotic Supplementation in IBS-D? A Cohort Study.
Marchix J, Quénéhervé L, Bordron P, Aubert P, et al · · 2023 · cited 7× · PMID 36838241 · DOI 10.3390/microorganisms11020277

Verify or expand the search:

Other trials of Lactibiane Tolerance

Trials testing the same drug.

NCT01529359 — Irritable Bowel Syndrome and Lactibiane Tolerance · NA · completed

Other PiLeJe trials

Trials by the same sponsor.

NCT04812418 — Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo · NA · completed
NCT04728269 — Exploratory Study on Lactibiane Topic AD on Skin Flora and Barrier Reinforcement in Mild to Moderate Atopic Dermatitis · NA · completed
NCT04574141 — Kinetic of Melatonin Subsequent to the Consumption of Melatonin-rich Food Supplements · NA · completed
NCT04628819 — Effect and Tolerability of Lactobacillus Rhamnosus GG LA801 for the Preventive Nutritional Care of Nosocomial Diarrhea i · NA · terminated
NCT04324658 — Effect and Tolerance of a Probiotic-based Medical Device Administered to Patients With Irritable Bowel Syndrome · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02728063 (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 PiLeJe
Last refreshed: 23 February 2021

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/NCT02728063.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing