Signs and Symptoms, Digestive
Conditions
Keywords
Fiber tolerability, Children
Brief summary
Assessment of the digestive tolerability of the PROMITOR® .
Detailed description
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.
Interventions
DRUGPROMITOR® (including Maltodextrin)
Investigational product dose 1
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
8 Years to 12 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the digestive tolerability of the Investigational Product (abdominal pain) | 7 days of intake | Using analog visual scale |
| Assessment of the digestive tolerability of the Investigational Product (rumbling) | 7 days of intake | Using analog visual scale |
| Assessment of the digestive tolerability of the Investigational Product (bloating) | 7 days of intake | Using analog visual scale |
| Assessment of the digestive tolerability of the Investigational Product (flatulence) | 7 days of intake | Using analog visual scale |
| Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency) | 7 days of intake | Using analog visual scale |
Countries
France, Switzerland
Outcome results
None listed