CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 124 enrolled
Drug / intervention
NUTRIOSE® +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05105425
NCT05105425N/ACompleted

The Effects of Daily Supplementation of Nutriose® on the Fecal Microbiota in Volunteers Over 4 Weeks: a Randomized, Double-blinded, Placebo Conrolled Pilot Study.

Roquette Freres·interventional·Posted Nov 3, 2021·Updated Apr 25, 2024

In Brief

A clinical study evaluating NUTRIOSE® and GLUCIDEX® IT21 (Placebo) for Healthy Male Volunteers. Completed, enrolled 124 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
CollaboratorsBioFortis

Timeline

N/ACompletedFinished
20222023202420252026
First PostedNov 3, 2021
Enrollment StartJul 19, 2021
Primary CompletionAug 7, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 4.7 years ago

Interventions

NUTRIOSE®dietary

After randomization (V2 visit), the subjects will consume per os, from V2 to V3, 1 sachet of 15g per day, in the morning, of active formula (NUTRIOSE®) during 4 weeks. They will consume 1 sachet in the morning. Powder will have to be mixed with usual beverage of the subject (whatever the type of drink, cold or hot).

GLUCIDEX® IT21 (Placebo)dietary

After randomization (V2 visit), the subjects will consume per os, from V2 to V3, 1 sachet of 15g per day, in the morning, of placebo during 4 weeks. They will consume 1 sachet in the morning. Powder will have to be mixed with usual beverage of the subject (whatever the type of drink, cold or hot).