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NCT07846254From ClinicalTrials.govRecruiting

The Effects of Daily Supplementation of a Soluble Fiber on the Fecal Microbiota in Volunteers.

The Effects of Daily Supplementation of NUTRIOSE® on the Fecal Microbiota in Healthy Adult Volunteers Over 4 Weeks: a Randomized, Double-blinded, Placebo-controlled Study

  • Healthy Volunteers

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Roquette Freres
Enrolment target
100
Started
31 August 2026
Main results due
April 2027
Study sites
1
Registry updated
29 September 2026

Can you take part?

  • Ages 18 years to 60 years.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Mérieux NutriSciences

    Addison, Illinois, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07846254. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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The Effects of Daily Supplementation of a Soluble Fiber on the Fecal Microbiota in Volunteers. | Trialion