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| Name | Class |
|---|---|
| BioFortis | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NUTRIOSE® | Active Comparator | 1 sachet to be taken at breakfast during 4 weeks |
|
| GLUCIDEX® IT21 | Placebo Comparator | 1 sachet to be taken at breakfast during 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NUTRIOSE® | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison at V3 of relative abundance of Parabacteroides genus in intestinal microbiota | Assessed via Shotgun metagenomics analysis | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison at V4 of relative abundance of Parabacteroides genus in intestinal microbiota. | Assessed via Shotgun metagenomics analysis | 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, ...) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Unit of Biofortis Paris | Paris | 75012 | France | |||
| Clinical Investigation Unit of Biofortis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42245546 | Derived | 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. |
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| ID | Term |
|---|---|
| C573352 | NUTRIOSE |
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A RANDOMIZED, DOUBLE-BLINDED, PLACEBO CONTROLLED PILOT STUDY
|
| GLUCIDEX® IT21 (Placebo) | Dietary Supplement | 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). |
|
Assessed via Shotgun metagenomics analysis |
| 2 weeks |
| Comparisons at V3 and V4 of intestinal parameters : Fecal pH | Assessed via laboratory analyse (no unit) | 2 weeks |
| Comparisons at V3 and V4 of intestinal parameters: Fecal short chain fatty acids (SCFA) | Assessed via laboratory analyse (µmol/g) | 2 weeks |
| Comparisons at V3 and V4 of intestinal parameters: Secretory immunoglobulin A in feces | Assessed via laboratory analyse (mg/g) | 2 weeks |
| The frequency of adverse events | Treatment-Emergent Adverse Events (TEAE), Serious treatment-emergent adverse events (STEAE), TEAEs leading to Investigational Product (IP) discontinuation, Treatment-Emergent Adverse Reaction (TEAR) and gastro-intestinal TEAE. | 7 or 8 weeks |
| Saint-Herblain |
| 44800 |
| France |