Fiber Tolerability in Children

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Assessment of the digestive tolerability of the PROMITOR® .

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nestlé

Criteria

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)