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The purpose of this study is to determine the optimal dose of soluble fibers that induces tolerable gastrointestinal symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | 8.0g oligosaccharide FODMAP A + 1.6g oligosaccharide FODMAP B |
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| Dose 2 | Experimental | 12g oligosaccharide FODMAP A + 2.4g oligosaccharide FODMAP B |
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| Dose 3 | Experimental | 16g oligosaccharide FODMAP A + 3.2g oligosaccharide FODMAP B |
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| Dose 4 | Experimental | 20g oligosaccharide FODMAP A + 4.0g oligosaccharide FODMAP B |
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| Placebo | Experimental | 8.0 g Dextrose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo challenge | Other | 2 sachets per day over 7-day challenge |
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| Measure | Description | Time Frame |
|---|---|---|
| Non-tolerance | Percentage of non-tolerance events as defined by participant dropping out due to digestive symptoms during the 7-day intervention phase | 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) | After 7 days of study product consumption |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After 7 days of study product consumption |
| Maximum score of digestive symptoms |
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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:
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?)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEN experimental | Dijon | France |
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Single blinded, Randomized, Parallel group
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| Fiber's mix (among 4 doses) |
| Other |
2 sachets per day over 7-day challenge |
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The maximum score of digestive symptoms from baseline (run-in) to day 7 of the intervention phase using the daily Visual Analog Scale (VAS) |
| 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 | 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 | 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) | After 7 days of study product consumption |
| 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 |