Fiber Tolerability in Children

Fiber Tolerability in Children

Assessment of the digestive tolerability of the PROMITOR® .

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.

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)