Signs and Symptoms, Digestive
Conditions
Keywords
Fiber tolerability, Children
Brief summary
Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years old.
Detailed description
The aim of the trial is to determine, using a dose escalation design, the digestive tolerability of the PROMITOR®given at the doses of 6, then 9 and finally 12 g (corresponding to 4, 6, and 8 g of fibers respectively) twice a day with the meals of the morning and of the evening versus control (maltodextrin, no fiber) over one week of intake in children from 3 to 7 years old. As it is an exploratory study there is no categorization between primary and secondary objectives.
Interventions
DRUGDose 1 - Promitor®
DRUGDose 2 - Promitor®
DRUGDose 3 - Promitor®
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the digestive tolerability of the Investigational Product (abdominal pain) using analog visual scale | 7 days of intake | Using analog visual scale |
| Assessment of the digestive tolerability of the Investigational Product (rumbling) using analog visual scale | 7 days of intake | Using analog visual scale |
| Assessment of the digestive tolerability of the Investigational Product (bloating) using analog visual scale | 7 days of intake | Using analog visual scale |
| Assessment of the digestive tolerability of the Investigational Product (flatulence) using analog visual scale | 7 days of intake | Using analog visual scale |
| Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency) using analog visual scale | 7 days of intake | Using analog visual scale |
Countries
France
Outcome results
None listed