RecruitingNot Applicable

Tolerance Profile of Soluble Fibers in Individuals With Self-perceived GI Sensitivity to Fibers (Tarine)

France173 participantsStarted 2025-11-13

Plain-language summary

The purpose of this study is to determine the optimal dose of soluble fibers that induces tolerable gastrointestinal symptoms.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18-60 years of age inclusive, and Body Mass Index (BMI) 18.5-29.9 kg/m2 inclusive; who according to the Rome IV fulfil criteria for self-perceived sensitivity to oligosaccharide FODMAP A and B including participants diagnosed with IBS, FBFB, or FBD-U.
✓. 18-60 years of age inclusive, and BMI 18.5-29.9 kg/m2 inclusive; who fulfil criteria for self-perceived sensitivity to oligosaccharide FODMAP A and B, not diagnosed with IBS, FB or FBD-U as per Rome IV Criteria but reporting abdominal pain at least once a week AND/OR bloating/distention at least once a week as per ROME IV diagnostic questionnaire.
✓. Individuals who fully understand the objectives of the study, who are willing to provide consent and agree to follow the protocol of the study.
✓. Participant is covered by French health insurance.
✓. Participant agrees to be registered in the national database of participants participating in clinical research.
✓. Participant is willing and able to complete the electronic Patient Reported Outcomes (ePRO) using a digital device (e.g. smartphone with minimal OS version of IOS 16.6 or android 11 or more recent) having access to internet (web site).
✓. Female participants must either be postmenopausal for at least 12 months or have undergone specific surgical procedures resulting in sterility (such as hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or they are using one of the medically approved contraceptive methods listed below from V1 until the end of the study, such as, but not exclusively:

Exclusion criteria

✕. Individuals who score below 75 or who score 300 or above on the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) if diagnosed with IBS using the Rome IV criteria.
✕. Individuals that are diagnosed with any other chronic gastrointestinal or metabolic disease or condition including inflammatory bowel disease, coeliac disease, fistulas or physiological/mechanical gastrointestinal obstruction, diverticulitis, gastric bezoar, radiation enteritis, suspected or known strictures.
✕. Change of dietary habits within the 4 weeks preceding V1 (e.g., start of a diet rich in fibers) or planned change (e.g., start of a new diet during study participation).
✕. Individuals with specific and extreme diets (e.g.: strict low-FODMAP, gluten free, high fiber diet, etc.).
✕. Individuals who anticipate changes to consumption of naturally probiotic/prebiotic containing foods e.g., yogurt with live cultures etc., in the next 2 months.
✕. Participant who has planned to participate in another clinical study during the period of this study OR participant involved in any other clinical study in the past four weeks.
✕. Participant with known allergy to any component of the study product(s).
✕. Individuals receiving any form of treatment likely to interfere with metabolism or dietary habits (e.g., anorexia, weight loss.).

What they're measuring

Non-tolerance

Timeframe: After 7 days of study product consumption

Score of the Digestive Symptoms Frequency Questionnaire (DSFQ)

Timeframe: After 7 days of study product consumption

Trial details

NCT IDNCT06877013

SponsorDanone Global Research & Innovation Center

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Danone Global Research & Innovation Center

+33 (0)1 69 35 70 00 register.clinicalresearchnutricia@danone.com

View on ClinicalTrials.gov More Population With Self-perceived Gastro-intestinal Sensitivity to Fibers trials