Fiber Tolerability in Children Aged 3-7 Year

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years old.

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

Details

• Lead Sponsor: Nestlé

Criteria

Inclusion Criteria:

1. Healthy children

2. Aged between 3 and 7 years old

3. Acceptance of the taste of the product

4. Having breakfast on daily basis

5. Consent and/or assent received according to regulation

6. Informed consent of both parents/guardians (in respect with the French regulation)

7. Parents/guardians affiliated to a health insurance (in respect with the French regulation)

Exclusion Criteria:

1. Specific food regimen

2. Intolerability or food allergy

3. Antibiotic or any medication impacting the gut transit during the 2 weeks before the study

4. Chronic gastrointestinal disease

5. Gastroenteritis in the 2 weeks preceding the study

6. Constipation or diarrhea based on ROMEIII criteria (in average: more than 3 stools per day or less than 3 stools per week)

7. Children and parents expected not to understand and perform the trial correctly (i.e.:

troubles in learning and/or speaking)

8. 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

9. Having participated in another clinical trial for 1 month, or currently participating in a clinical trial

10. Under legal protection or deprived from his rights following administrative or judicial decision (in respect with the French regulation)