NCT05105425 (NUTRIBIOTE) is a NA clinical trial of NUTRIOSE® in Healthy Male Volunteers, sponsored by Roquette Freres.

Who is sponsoring NCT05105425?

NCT05105425 is sponsored by Roquette Freres.

What drugs are being tested in NCT05105425?

Interventions in NCT05105425: NUTRIOSE®, GLUCIDEX® IT21 (Placebo).

What condition does NCT05105425 study?

NCT05105425 studies Healthy Male Volunteers.

Is NCT05105425 still recruiting?

NCT05105425 is currently completed. Last updated 25 April 2024.

Last reviewed 2024-04-25 · How we verify

NCT05105425: NUTRIBIOTE

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

The Effects of Daily Supplementation of Nutriose® on the Fecal Microbiota in Volunteers.

Completed NA Last updated 25 April 2024

What this trial tests

NA trial testing NUTRIOSE® in Healthy Male Volunteers in 124 participants. Completed in 7 August 2023.

Timeline

19 July 2021

Primary endpoint
7 August 2023

7 August 2023

Quick facts

Lead sponsor	Roquette Freres
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	124
Start date	19 July 2021
Primary completion	7 August 2023
Estimated completion	7 August 2023
Sites	2 locations across France

Drugs / interventions tested

NUTRIOSE®
GLUCIDEX® IT21 (Placebo)

Conditions studied

Healthy Male Volunteers — all drugs for Healthy Male Volunteers →

Sponsor

Roquette Freres

Who can join

Adults 18 to 60, male only, with Healthy Male Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The effects of daily supplementation of the NUTRIOSE® on the fecal microbiota. The hypothesis of the study is that the NUTRIOSE® is able to modulate the intestinal microbiota in a positive way, compare to a placebo, in healthy volunteers.

Publications & conference data

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

Resistant dextrin promotes beneficial fecal bacteria in high and low fiber diet populations: a randomized, double-blinded, controlled pilot study.
Perreau C, Tomassi D, Capronnier O, Carton T, et al · · 2026 · PMID 42245546 · DOI 10.3389/fnut.2026.1810842

Verify or expand the search:

Other recruiting trials for Healthy Male Volunteers

Currently open trials in the same condition.

NCT07479745 — Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019 · Phase 1 · recruiting

Other Roquette Freres trials

Trials by the same sponsor.

NCT06381869 — Bioavailability of Pea Protein in Young and Old Volunteers · NA · 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 NCT05105425 (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 Roquette Freres
Last refreshed: 25 April 2024

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/NCT05105425.

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