NCT07846254 The Effects of Daily Supplementation of a Soluble Fiber on the Fecal Microbiota in Volunteers.
| NCT ID | NCT07846254 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Roquette Freres |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-08-31 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-08-31 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The effects of daily supplementation with NUTRIOSE® on the fecal microbiota. The study aims to evaluate the ability of NUTRIOSE® to support a beneficial modulation of the intestinal microbiota in healthy volunteers, compared with a placebo.
Eligibility Criteria
Inclusion Criteria: * Men and women aged ≥ 18 and ≤ 60 years; * Body mass index (BMI) ≥ 18 and ≤ 30 kg/m²; * With a usual normal intestinal transit (according to BSS). According to stool questionnaire completed between V0 and V1, mean of the 7 days of completion, maximum 3 stools / day and 3 stools/week minimum and with mean normal consistency * Good general and mental health according to the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination; * Agreement to maintain lifestyle habits during the study (same dietary and physical habits); * Able and willing to participate in the study by complying with the protocol procedures as evidenced by a dated and signed informed consent form (ICF); * Affiliated with a social security scheme; Exclusion Criteria: * Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder; * Suffering from gastrointestinal disorders such as celiac disease, Crohn's disease, functional constipation, irritable bowel syndrome or another gastrointestinal found to be inconsistent with the study according to the investigator; * Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, uncontrolled cardiac disease, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or another severe disorders found to be inconsistent with the conduct of the study by the investigator; * With a known food allergy or intolerance or hypersensitivity to any ingredient of the IP; * Pregnant or lactating women or intending to become pregnant within 6 months ahead; * Having undergone recent surgical procedure in the past 6 months or planned on the 2 months to come; * Under treatment which could significantly affect parameter(s) followed during the study according to the investigator or stopped less than 4 weeks before the V0 visit, i.e. medication with impact on intestinal transit such as anti-diarrheal, anti-spasmodic,antidepressants antibiotics, antacids, laxative, antifungal, NSAI, anti-vomiting, GLP-1 receptor agonists, corticoids, opioids, narcotic analgesic and biliary acids chelator, and chronic hormonal treatment started less than 3 months ago (i.e. new method of hormonal contraception, thyroidal trouble treatment); * Regular intake of dietary supplements or "health foods", or products known to impact intestinal microbiota, containing or rich in prebiotics, probiotics, symbiotic, fibre, fermented milk or yogurt, kefir, ultra-yeast, vitamins and minerals, or stopped less than 3 months before the inclusion visit. * With significant change in dietary or physical activity habits in the 3 months before randomization (no hyper or hypocaloric diet, no high-protein diet, no prolonged fasting for more than one week, no planned change in the level of sports activity in the next 3 months); * Taking part in another clinical study or being in the exclusion period of a previous clinical study; * Under legal protection (guardianship, wardship) or deprived of his rights following the administrative or judicial decision; * Presenting psychological or linguistic incapability to sign the ICF; * Impossible to contact in case of emergency.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07846254 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07846254 currently recruiting?
Yes, NCT07846254 is actively recruiting participants. Contact the research team at elizabeth.antoo@mxns.com for enrollment information.
Where is the NCT07846254 trial being conducted?
This trial is being conducted at Addison, United States.
Who is sponsoring the NCT07846254 clinical trial?
NCT07846254 is sponsored by Roquette Freres. The trial plans to enroll 100 participants.