NCT03539913 (SABINA) is a Phase 4 clinical trial of Probiotic : Saccharomyces boulardii in Acute Gastroenteritis, sponsored by Biocodex.

Who is sponsoring NCT03539913?

NCT03539913 is sponsored by Biocodex.

What drugs are being tested in NCT03539913?

Interventions in NCT03539913: Probiotic : Saccharomyces boulardii, Probiotic : Bacillus clausii.

What condition does NCT03539913 study?

NCT03539913 studies Acute Gastroenteritis.

Is NCT03539913 still recruiting?

NCT03539913 is currently completed. Last updated 22 January 2019.

Last reviewed 2019-01-22 · How we verify

NCT03539913: SABINA

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

Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children

Completed Phase 4 Last updated 22 January 2019

What this trial tests

Phase 4 trial testing Probiotic : Saccharomyces boulardii in Acute Gastroenteritis in 317 participants. Completed in 9 June 2018.

Timeline

19 June 2017

Primary endpoint
9 June 2018

9 June 2018

Quick facts

Lead sponsor	Biocodex
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	317
Start date	19 June 2017
Primary completion	9 June 2018
Estimated completion	9 June 2018
Sites	8 locations across Argentina

Drugs / interventions tested

Probiotic : Saccharomyces boulardii — full drug profile →
Probiotic : Bacillus clausii — full drug profile →

Conditions studied

Acute Gastroenteritis — all drugs for Acute Gastroenteritis →

Sponsor

Biocodex — full company profile →

Who can join

Adults 6 Months to 5, any sex, with Acute Gastroenteritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* Primary Objective: o To assess the efficacy of the probiotics in reducing the duration of diarrhea in children suffering from acute gastroenteritis. * Secondary Objectives: * To assess the efficacy of the probiotics in improving the frequency and consistency of stools. * To assess the efficacy of the probiotics in avoiding recurrence of diarrhea. * To assess the efficacy of the probiotics on the disease severity. * To assess the safety and tolerability of the studied probiotics.

Publications & conference data

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

Probiotics for treating acute infectious diarrhoea.
Collinson S, Deans A, Padua-Zamora A, Gregorio GV, et al · · 2020 · cited 84× · PMID 33295643 · DOI 10.1002/14651858.cd003048.pub4
Randomized, direct comparison study of Saccharomyces boulardii CNCM I-745 versus multi-strained Bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis.
Altcheh J, Carosella MV, Ceballos A, D'Andrea U, et al · · 2022 · cited 7× · PMID 36086703 · DOI 10.1097/md.0000000000030500
Safety and efficacy concerns in Indian probiotics: Insights from whole-genome sequencing and <i>in vitro</i> assessment.
Madhumathi I, Ramesh V, Rathakrishnan B, Abirami B, et al · · 2026 · PMID 42145944 · DOI 10.1080/29933935.2026.2668863

Verify or expand the search:

Other recruiting trials for Acute Gastroenteritis

Currently open trials in the same condition.

NCT06592794 — A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute · Phase 3 · active not recruiting

Other Biocodex trials

Trials by the same sponsor.

NCT07168434 — Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome · Phase 3 · recruiting
NCT07176832 — Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ) · Phase 1 · completed
NCT06282614 — Performance and Safety of MUCOGYNE® Ovule as a Moisturizer · NA · terminated
NCT05913479 — Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer · NA · completed
NCT05735951 — Pharmacokinetic Parameters of Stiripentol in Renal Impaired Patients and Matching Controls With Normal Renal Function · Phase 1 · 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 NCT03539913 (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 Biocodex
Last refreshed: 22 January 2019

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/NCT03539913.

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