Population With Self-perceived Gastro-intestinal Sensitivity to Fibers
Conditions
Keywords
Exploratory, Monocentric, Single blinded, Randomized, Multi-dose, Soluble fibers, Gastro-intestinal sensitivity, Parallel study, Placebo-challenge
Brief summary
The purpose of this study is to determine the optimal dose of soluble fibers that induces tolerable gastrointestinal symptoms.
Interventions
OTHERPlacebo challenge
2 sachets per day over 7-day challenge
OTHERFiber's mix (among 4 doses)
2 sachets per day over 7-day challenge
Sponsors
Danone Global Research & Innovation Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
Single blinded, Randomized, Parallel group
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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 oligosaccharide FODMAP A and B including participants 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 at least once a week AND/OR bloating/distention at least 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. Participant is covered by French health insurance. 5. Participant agrees to be registered in the national database of participants participating in clinical research. 6. 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). 7. 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.
Exclusion criteria
1. 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. 2. 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. 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. 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. 7. Participant 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. Participant 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 potential central nervous system effects as judged by the investigator. 11. Individuals with previous digestive surgery (except for appendectomy performed more than 2 years ago). 12. 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). 13. Oral disease or medical condition that may impact on hydrogen and methane breath sampling (e.g., gingivitis, halitosis, oral thrush, candidiasis, asthma). 14. 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. 15. Individuals who take supplements used to treat bloating: activated charcoal, enzymes (ex: lactase, alpha galactosidase, fructanase). 16. Women who report they are pregnant/lactating/planning pregnancy. 17. Recent/ongoing consumption of probiotics/prebiotic/synbiotics supplements (past 28 days). 18. Participant is a smoker (usual use of any tobacco products, nicotine, nicotinecontaining products or all types of e-cigarette in the previous 3 months). 19. Alcohol consumption that exceeds the recommended amounts (\>10 standard glasses per week or \> 2 standard glasses per day). 20. Participant living in the same home as a participant currently participating in this study. 21. 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). 22. Employees and/or children/family members or relatives of employees of Danone Global Research \& Innovation Center or the investigational sites. 23. 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). 24. Participant admitted to a health or social care facility 25. 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). 26. Having received, during the last 12 months, indemnities for participation into clinical studies exceeding the annual threshold of 6000€ (including participation to this study). 27. Individual whom are not able to follow Protocol instructions and restrictions (i.e. night workers). Secondary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-tolerance | 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) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) score | After 7 days of study product consumption | 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 |
| Maximum score of digestive symptoms | After 7 days of study product consumption | The maximum score of digestive symptoms from baseline (run-in) to day 7 of the intervention phase using the daily Visual Analog Scale (VAS) |
| The time to maximum score of digestive symptoms | After 7 days of study product consumption | 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 |
| incremental Area Under Curve (iAUC) | After 7 days of study product consumption | The daily Visual Analog Scale (VAS) score incremental Area Under Curve (iAUC) from baseline (run-in) to day 7 of the intervention phase |
| Digestive Symptoms Frequency Questionnaire (DSFQ) | After 7 days of study product consumption | 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) |
| Daily VAS at run-in phase | After 7 days without product consumption | — |
| Stool Frequency Questionnaires (SFQ) at run-in phase | After 7 days without product consumption | — |
| Bristol Stool Scale (BSS) at run-in phase | After 7 days without product consumption | — |
| Food Frequency Questionnaire (FFQ) at V3 | After 7 days without product consumption | — |
| Nutrient daily intake and food group daily intake (MyFood24) at run-in phase | After 7 days without product consumption | — |
| FODMAP daily content (Monash calculator) at run-in phase | After 7 days without product consumption | — |
| DSFQ (total score and the 4 symptom sub-scores) at the run-in phase | After 7 days without product consumption | — |
| Rome IV at V1 (IBS, FB, U-FBD, abdominal pain, bloating/distention at least once a week) | At inclusion | — |
| Breath hydrogen concentration (ppm - OMED health device by Owlstone Medical) from baseline (run-in) to day 7 of the intervention phase | 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 | After 7 days of study product consumption | — |
| Association between breath hydrogen and methane concentrations and DSFQ and VAS scores | After 7 days of study product consumption | — |
| Association between breath hydrogen and methane concentrations and VAS score | After 7 days of study product consumption | — |
Countries
France
Contacts
CONTACTDanone Global Research & Innovation Center
Outcome results
None listed