Clinical trial NCT06877013: Tolerance Profile of Soluble Fibers in Individuals With Self-perceived GI Sensitivity to Fibers (Tarine)
Official title: An Exploratory, Randomized, Single Blinded, Monocentric, Parallel Group Study to Explore the Tolerance Profile of Soluble Fibers in Individuals With Self-perceived Gastrointestinal Sensitivity to Fibers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Population With Self-perceived Gastro-intestinal Sensitivity to Fibers
Keywords: Exploratory
Monocentric
Single blinded
Randomized
Multi-dose
Soluble fibers
Gastro-intestinal sensitivity
Parallel study
Placebo-challenge
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2025-03-14
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded, Randomized, Parallel group
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: Inclusion Criteria:

1. 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 fructans and/or α-GOS and including subjects diagnosed with IBS, FBFB, or FBD-U.
2. 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 once a week AND/OR bloating/distention once a week as per ROME IV diagnostic questionnaire.
3. Individuals who fully understand the objectives of the study, who are willing to provide consent and agree to follow the protocol of the study.
4. Subject is covered by French health insurance.
5. Subject agrees to be registered in the national database of subjects participating in clinical research.
6. Subject is willing and able to complete the electronic Patient Reported Outcomes (ePRO) using their digital device (e.g. smartphone) having access to internet (web site).
7. Female subjects 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:
8. Oral contraception
9. Intra-uterine device (IUD)
10. Double barrier method (e.g., condoms and spermicide)
11. Abstinence, when the opinion of the investigator, their occupation or lifestyle gives efficient evidence that abstinence will be maintained throughout the study and for one month thereafter.

Exclusion Criteria:

1. Individuals who score above 300 on the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) if diagnosed with IBS using the Rome IV criteria.
2. Individuals that are diagnosed with any other chronic gastrointestinal disease or condition including inflammatory bowel disease, coeliac disease, fistulas or physiological/mechanical gastrointestinal obstruction, diverticulitis, gastric bezoar, radiation enteritis, suspected or known strictures.
3. 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).
4. Individuals with specific and extreme diets (e.g.: strict low-FODMAP, gluten free, high fiber diet, etc.).
5. Individuals who anticipate changes to consumption of naturally probiotic/prebiotic containing foods e.g., yogurt with live cultures etc., in the next 2 months.
6. Subject who has planned to participate in another clinical study during the period of this study OR subject involved in any other clinical study in the past four weeks.
7. Subject with known allergy to any component of the study product(s).
8. Individuals receiving any form of treatment likely to interfere with metabolism or dietary habits (e.g., anorexia, weight loss.).
9. Subject with any intake of antibiotics or intestinal antiseptics in the previous month (within 30 days) prior to screening visit (V1).
10. Individuals with current use of medication with central nervous system effects as judged by the investigator.
11. Individuals with previous digestive surgery (except for appendectomy and cholecystectomy performed more than 2 years ago).
12. Subjects performing strenuous daily exercise for more than 1.5 hours at a time (e.g., intensive daily cardio for more than 1.5 hours).
13. Oral disease that may impact on hydrogen and methane breath sampling e.g., gingivitis, halitosis, oral thrush, candidiasis.
14. Individuals with swallowing troubles (e.g., dysphagia) that may impact smart pill ingestion.
15. Subject with any intake of drugs that might modify gastrointestinal function (e.g., regular use of laxatives, anti-diarrheal agents, anti-emetics, prokinetics, proton pump inhibitors (PPIs), NSAIDs, antacids, etc.).
16. Individuals who take supplements used to treat bloating: activated charcoal, enzymes (ex: lactase, alpha galactosidase, fructanase).
17. Women who report they are pregnant/lactating/planning pregnancy.
18. Recent/ongoing consumption of probiotics/prebiotic supplements (past 28 days).
19. Subject is a smoker (use of any tobacco products, nicotine, or nicotine-containing products in the previous 3 months).
20. Alcohol consumption that exceeds the recommended amounts (\>10 standard glasses per week or \> 2 standard glasses per day).
21. Patients with implantable or portable electromechanical medical devices (e.g., pacemaker).
22. Subject living in the same home as a subject currently participating in this evaluation.
23. Subjects defined as individuals whose willingness to volunteer in the clinical trial may be unduly influenced by benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. (Examples are members of a group with a hierarchical structure linked to the Investigator or to the Sponsor, such as students, subordinate hospital and laboratory personnel, employees of the Investigator or of the Sponsor, relatives of the Sponsor).
24. Employees and/or children/family members or relatives of employees of Danone Global Research \& Innovation Center or the participating sites.
25. Belonging to a population covered by articles L.1121-6 (persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care), and L.1121.8 (adults under legal protection or unable to express their consent) of the CSP (French Public Health Code).
26. Individuals admitted to a healthcare or social institution.

Primary outcomes:
measure: Non-tolerance
timeFrame: After 7 days of study product consumption
measure: Score of the Digestive Symptoms Frequency Questionnaire (DSFQ)
timeFrame: After 7 days of study product consumption
measure: Breath hydrogen and methane concentration from breath test
timeFrame: After 7 days of study product consumption
measure: Breath hydrogen concentration from smart pill
timeFrame: After 7 days of study product consumption
Secondary outcomes:
measure: Visual Analog Scale (VAS) score
timeFrame: After 7 days of study product consumption
measure: Maximum score of digestive symptoms
timeFrame: After 7 days of study product consumption
measure: The time to maximum score of digestive symptoms
timeFrame: After 7 days of study product consumption
measure: incremental Area Under Curve (iAUC)
timeFrame: After 7 days of study product consumption
measure: Digestive Symptoms Frequency Questionnaire (DSFQ)
timeFrame: After 7 days of study product consumption
Other outcomes:
Locations:
city: Dijon
country: France
facility: CEN experimental
Study officials:
References: