Population With Self-perceived Gastro-intestinal Sensitivity to FibersTarineNCT06877013

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

A study testing Fiber's mix (among 4 doses) in people with Population With Self-perceived Gastro-intestinal Sensitivity to Fibers, run by Danone Global Research & Innovation Center at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Population With Self-perceived Gastro-intestinal Sensitivity to Fibers
What is being tested?: Fiber's mix (among 4 doses)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 141 participants
Where: 1 siteFrance
Study dates: 13 Nov 2025to 12 Jun 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

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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:
oral contraception
intra-uterine device (IUD)
double barrier method (e.g., condoms and spermicide)
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.

Who cannot join

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.

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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.).
Participant with any intake of antibiotics or intestinal antiseptics in the previous month (within 30 days) prior to screening visit (V1).
Individuals with current use of medication with potential central nervous system effects as judged by the investigator.
Individuals with previous digestive surgery (except for appendectomy performed more than 2 years ago).
Participants performing strenuous daily exercise for more than 1.5 hours at a time (e.g., intensive daily cardio for more than 1.5 hours).
Oral disease or medical condition that may impact on hydrogen and methane breath sampling (e.g., gingivitis, halitosis, oral thrush, candidiasis, asthma).
Participant 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.) or breath function (e.g. aerosol) in the past 8 weeks or, plan to use.
Individuals who take supplements used to treat bloating: activated charcoal, enzymes (ex: lactase, alpha galactosidase, fructanase).
Women who report they are pregnant/lactating/planning pregnancy.
Recent/ongoing consumption of probiotics/prebiotic/synbiotics supplements (past 28 days).
Participant is a smoker (usual use of any tobacco products, nicotine, nicotinecontaining products or all types of e-cigarette in the previous 3 months).
Alcohol consumption that exceeds the recommended amounts (>10 standard glasses per week or > 2 standard glasses per day).
Participant living in the same home as a participant currently participating in this study.
Participants defined as individuals whose willingness to volunteer in the clinical trial may be unduly influenced by the expectation, whether justified or not, of 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).
Employees and/or children/family members or relatives of employees of Danone Global Research \& Innovation Center or the investigational sites.
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).
Participant admitted to a health or social care facility
Individuals with a known case of diabetes mellitus (type 1 or type 2), or those with a known HbA1c ≥ 6.5% at screening, or currently receiving antidiabetic treatment (oral or injectable).
Having received, during the last 12 months, indemnities for participation into clinical studies exceeding the annual threshold of 6000€ (including participation to this study).
Individual whom are not able to follow Protocol instructions and restrictions (i.e. night workers).
Secondary exclusion criteria:
Exclusion criteria at the end of the "placebo challenge" (Visit 2):
1. Participant "nocebo responder", defined as a participant who reports "Worse" at the question related to overall digestive symptom ("How do you consider in the past 7 days, your GI well-being (intestinal transit, stool frequency and consistency, abdominal pain/discomfort, bloating, flatulence/passage of gas, borborygmi/rumbling stomach) compared to the period before beginning the consumption of the study product?)

Trial locations and contacts

1 site in 1 country.

France1 site

CEN experimental
Dijon

Other trials in France

About this study

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

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

Conditions: Population With Self-perceived Gastro-intestinal Sensitivity to Fibers
Being tested: Placebo challenge, Fiber's mix (among 4 doses)
Keywords: Exploratory, Monocentric, Single blinded, Randomized, Multi-dose, Soluble fibers, Gastro-intestinal sensitivity, Parallel study, Placebo-challenge

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo challengeOther
2 sachets per day over 7-day challenge
Fiber's mix (among 4 doses)Other
2 sachets per day over 7-day challenge

Study groups in NCT06877013
Study group	Role	What they receive
Dose 1	Experimental	8.0g oligosaccharide FODMAP A + 1.6g oligosaccharide FODMAP B Receives: Other: Fiber's mix (among 4 doses)
Dose 2	Experimental	12g oligosaccharide FODMAP A + 2.4g oligosaccharide FODMAP B Receives: Other: Fiber's mix (among 4 doses)
Dose 3	Experimental	16g oligosaccharide FODMAP A + 3.2g oligosaccharide FODMAP B Receives: Other: Fiber's mix (among 4 doses)
Dose 4	Experimental	20g oligosaccharide FODMAP A + 4.0g oligosaccharide FODMAP B Receives: Other: Fiber's mix (among 4 doses)
Placebo	Experimental	8.0 g Dextrose Receives: Other: Placebo challenge

What is being measured

The primary outcome is the main question the study is designed to answer.

Non-tolerance
Percentage of non-tolerance events as defined by participant dropping out due to digestive symptoms during the 7-day intervention phase
Measured: After 7 days of study product consumption
Score of the Digestive Symptoms Frequency Questionnaire (DSFQ)
The absolute change from baseline (run-in) to day 7 of the intervention phase on the total score of the Digestive Symptoms Frequency Questionnaire (DSFQ)
Measured: After 7 days of study product consumption

Secondary outcomes (17)

Visual Analog Scale (VAS) score
The absolute change of digestive symptoms from baseline (run-in) to day 7 of the intervention phase on the daily Visual Analog Scale (VAS) score
Measured: After 7 days of study product consumption
Maximum score of digestive symptoms
The maximum score of digestive symptoms from baseline (run-in) to day 7 of the intervention phase using the daily Visual Analog Scale (VAS)
Measured: After 7 days of study product consumption
The time to maximum score of digestive symptoms
The time to maximum score of digestive symptoms (Tmax) on the daily Visual Analog Scale (VAS) from baseline (run-in) to day 7 of the intervention phase
Measured: After 7 days of study product consumption
incremental Area Under Curve (iAUC)
The daily Visual Analog Scale (VAS) score incremental Area Under Curve (iAUC) from baseline (run-in) to day 7 of the intervention phase
Measured: After 7 days of study product consumption
Digestive Symptoms Frequency Questionnaire (DSFQ)
The absolute change from baseline (run-in) to day 7 of the intervention phase on individual symptoms scores (4 symptoms sub-scores) of the Digestive Symptoms Frequency Questionnaire (DSFQ)
Measured: After 7 days of study product consumption
Daily VAS at run-in phase
Measured: After 7 days without product consumption
Stool Frequency Questionnaires (SFQ) at run-in phase
Measured: After 7 days without product consumption
Bristol Stool Scale (BSS) at run-in phase
Measured: After 7 days without product consumption
Food Frequency Questionnaire (FFQ) at V3
Measured: After 7 days without product consumption
Nutrient daily intake and food group daily intake (MyFood24) at run-in phase
Measured: After 7 days without product consumption
FODMAP daily content (Monash calculator) at run-in phase
Measured: After 7 days without product consumption
DSFQ (total score and the 4 symptom sub-scores) at the run-in phase
Measured: After 7 days without product consumption
Rome IV at V1 (IBS, FB, U-FBD, abdominal pain, bloating/distention at least once a week)
Measured: At inclusion
Breath hydrogen concentration (ppm - OMED health device by Owlstone Medical) from baseline (run-in) to day 7 of the intervention phase
Measured: After 7 days of study product consumption
Breath methane concentration (ppm - OMED health device by Owlstone Medical) from baseline (run-in) to day 7 of the intervention phase
Measured: After 7 days of study product consumption
Association between breath hydrogen and methane concentrations and DSFQ and VAS scores
Measured: After 7 days of study product consumption
Association between breath hydrogen and methane concentrations and VAS score
Measured: After 7 days of study product consumption

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 202512 Jun 2026

First posted14 Mar 2025
Study start13 Nov 2025
Primary completion6 May 2026
Study completion12 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Population With Self-perceived Gastro-intestinal Sensitivity to FibersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single blinded, Randomized, Parallel group
Masking: Single blind
Who is masked: Participant
Enrolment: 141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06877013
Sponsor's protocol ID: 23REX0061999
Acronym: Tarine
Status last verified: Jun 2026
First submitted: 17 Feb 2025
Last updated: 16 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06877013
Acronym / sponsor ID: Tarine / 23REX0061999
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 141 participants (actual)
Lead sponsor: Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
Study start: 13 Nov 2025 (actual)
Primary completion: 6 May 2026 (actual)
Study completion: 12 Jun 2026 (actual)
First posted: 14 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 5
Model description: Single blinded, Randomized, Parallel group

Arm	Type	Receives
Dose 1	Experimental	Other: Fiber's mix (among 4 doses)8.0g oligosaccharide FODMAP A + 1.6g oligosaccharide FODMAP B
Dose 2	Experimental	Other: Fiber's mix (among 4 doses)12g oligosaccharide FODMAP A + 2.4g oligosaccharide FODMAP B
Dose 3	Experimental	Other: Fiber's mix (among 4 doses)16g oligosaccharide FODMAP A + 3.2g oligosaccharide FODMAP B
Dose 4	Experimental	Other: Fiber's mix (among 4 doses)20g oligosaccharide FODMAP A + 4.0g oligosaccharide FODMAP B
Placebo	Experimental	Other: Placebo challenge8.0 g Dextrose

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (30 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo challenge2 sachets per day over 7-day challenge	Other	Placebo
Fiber's mix (among 4 doses)2 sachets per day over 7-day challenge	Other	Dose 1, Dose 2, Dose 3, Dose 4

Primary outcome

Non-tolerance
Time frame: After 7 days of study product consumption
Percentage of non-tolerance events as defined by participant dropping out due to digestive symptoms during the 7-day intervention phase
Score of the Digestive Symptoms Frequency Questionnaire (DSFQ)
Time frame: After 7 days of study product consumption
The absolute change from baseline (run-in) to day 7 of the intervention phase on the total score of the Digestive Symptoms Frequency Questionnaire (DSFQ)

17 secondary outcomes

Visual Analog Scale (VAS) score
Time frame: After 7 days of study product consumption
Maximum score of digestive symptoms
Time frame: After 7 days of study product consumption
The time to maximum score of digestive symptoms
Time frame: After 7 days of study product consumption
incremental Area Under Curve (iAUC)
Time frame: After 7 days of study product consumption
Digestive Symptoms Frequency Questionnaire (DSFQ)
Time frame: After 7 days of study product consumption
Daily VAS at run-in phase
Time frame: After 7 days without product consumption
Stool Frequency Questionnaires (SFQ) at run-in phase
Time frame: After 7 days without product consumption
Bristol Stool Scale (BSS) at run-in phase
Time frame: After 7 days without product consumption
Food Frequency Questionnaire (FFQ) at V3
Time frame: After 7 days without product consumption
Nutrient daily intake and food group daily intake (MyFood24) at run-in phase
Time frame: After 7 days without product consumption
FODMAP daily content (Monash calculator) at run-in phase
Time frame: After 7 days without product consumption
DSFQ (total score and the 4 symptom sub-scores) at the run-in phase
Time frame: After 7 days without product consumption
Rome IV at V1 (IBS, FB, U-FBD, abdominal pain, bloating/distention at least once a week)
Time frame: At inclusion
Breath hydrogen concentration (ppm - OMED health device by Owlstone Medical) from baseline (run-in) to day 7 of the intervention phase
Time frame: After 7 days of study product consumption
Breath methane concentration (ppm - OMED health device by Owlstone Medical) from baseline (run-in) to day 7 of the intervention phase
Time frame: After 7 days of study product consumption
Association between breath hydrogen and methane concentrations and DSFQ and VAS scores
Time frame: After 7 days of study product consumption
Association between breath hydrogen and methane concentrations and VAS score
Time frame: After 7 days of study product consumption

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-tolerance (time frame: After 7 days of study product consumption). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06877013.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.