Fiber Tolerability in Children

Study Overview
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Brief Summary
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Assessment of the digestive tolerability of the PROMITOR® .

Detailed Description
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The trial will be multicenter, double-blind, placebo-controlled, randomized with a 4-arm parallel-design. The subjects wil be randomized to one of the four arms, i.e. four doses of investigational product balanced in maltodextrin, given at the doses of 6, 9 or 12 g (corresponding to 4, 6, or 8 g of fibers) twice a day with the meals of the morning and of the evening versus control (maltodextrin, no fibers) over one week of intake. The total sample size is 40 healthy children from 8 to 12 years old, male and female.

Official Title
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Fiber Tolerability in Children

Conditions
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Signs and Symptoms, Digestive

Intervention / Treatment
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* Drug: Placebo (including Maltodextrin)
* Drug: PROMITOR® (including Maltodextrin)
* Drug: PROMITOR® (including Maltodextrin)
* Drug: PROMITOR® (including Maltodextrin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children, Aged between 8 and 12 years old included Acceptance of the taste of the product Having breakfast on daily basis Consent and/or assent received according to regulation Informed consent of one of the parents/guardians (for the study to be conducted in Switzerland, in respect with the Swiss regulation) or Informed consent of both parents/guardians (for the study to be conducted in France, in respect with the French regulation) Parents/guardians affiliated to a health insurance (only for the study to be conducted in France, in respect with the French regulation) Exclusion Criteria: Specific food regimen Intolerability or food allergy Antibiotic or any medication impacting the gut transit during the 2 weeks before the study Chronic gastrointestinal disease Gastroenteritis in the 2 weeks preceding the study Constipation or diarrhea based on ROMEIII criteria (in average: more than 3 stools per day or less than 3 stools per week) Children and parents expected not to understand and perform the trial correctly (i.e.: troubles in learning and/or speaking) Child in a situation which, in the opinion of the principal investigator, could interfere with the optimal participation to the study or constitute a particular risk of non-compliance Having participated in another clinical trial for 1 month, or currently participating in a clinical trial Under legal protection or deprived from his rights following administrative or judicial decision (only for the study to be conducted in France, in respect with the French regulation)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo (including Maltodextrin)<br> <br> |
| Active Comparator: PROMITOR® dose 1<br>Investigational product dose 1 | Drug: PROMITOR® (including Maltodextrin)<br>* Investigational product dose 1<br>|
| Active Comparator: PROMITOR® dose 2<br>Investigational product dose 2 | Drug: PROMITOR® (including Maltodextrin)<br>* Investigational product dose 2<br>|
| Active Comparator: PROMITOR® dose 3<br>Investigational product dose 3 | Drug: PROMITOR® (including Maltodextrin)<br>* Investigational product dose 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the digestive tolerability of the Investigational Product (abdominal pain) | Using analog visual scale | 7 days of intake | 
| Assessment of the digestive tolerability of the Investigational Product (rumbling) | Using analog visual scale | 7 days of intake | 
| Assessment of the digestive tolerability of the Investigational Product (bloating) | Using analog visual scale | 7 days of intake | 
| Assessment of the digestive tolerability of the Investigational Product (flatulence) | Using analog visual scale | 7 days of intake | 
| Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency) | Using analog visual scale | 7 days of intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fiber tolerability, Children