The Effects of Daily Supplementation of Nutriose® on the Fecal Microbiota in Volunteers.
NUTRIBIOTE
NUTRIBIOTE
Sponsor study identifier
interventional
124
1 country
2
Study Start
July 19, 2021
Actual (reported)Primary Completion
August 7, 2023
Actual (reported)Study Completion
August 7, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 7, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2021
Actual (reported)July 19, 2021
Actual (reported)November 3, 2021
Actual (reported)August 7, 2023
Actual (reported)August 7, 2023
Actual (reported)Comparison at V3 of relative abundance of Parabacteroides genus in intestinal microbiota
Assessed via Shotgun metagenomics analysis
4 weeks
Comparison at V4 of relative abundance of Parabacteroides genus in intestinal microbiota.
7 or 8 weeks
Comparisons at V3 and V4 of relative abundance of intestinal microbiota (Bacterial species of Parabacteroides genus, Bacteroides genus, Firmicutes phylum, the functional levels of the intestinal microbiota, ...)
2 weeks
Comparisons at V3 and V4 of intestinal parameters : Fecal pH
2 weeks
Comparisons at V3 and V4 of intestinal parameters: Fecal short chain fatty acids (SCFA)
2 weeks
Comparisons at V3 and V4 of intestinal parameters: Secretory immunoglobulin A in feces
2 weeks
1 sachet to be taken at breakfast during 4 weeks
1 sachet to be taken at breakfast during 4 weeks
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).
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).
Clinical Investigation Unit of Biofortis Paris
Paris, 75012, France
Clinical Investigation Unit of Biofortis
Saint-Herblain, 44800, France
Perreau C, Tomassi D, Capronnier O, Carton T, Thabuis C, Guerin-Deremaux L. Resistant dextrin promotes beneficial fecal bacteria in high and low fiber diet populations: a randomized, double-blinded, controlled pilot study. Front Nutr. 2026 May 20;13:1810842. doi: 10.3389/fnut.2026.1810842. eCollection 2026.
124 participants (actual enrollment reported by the registry).
First Submitted
July 1, 2021
First Posted
November 3, 2021
Study Start
July 19, 2021
Actual (reported)Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
August 7, 2023
Actual (reported)Study Completion
August 7, 2023
Actual (reported)Last Updated
April 25, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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