Fiber Tolerability in Children
- Conditions
- Signs and Symptoms, Digestive
- Interventions
- Drug: PROMITOR® (including Maltodextrin)Drug: Placebo (including Maltodextrin)
- Registration Number
- NCT02519374
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PROMITOR® dose 1 PROMITOR® (including Maltodextrin) Investigational product dose 1 Placebo Placebo (including Maltodextrin) Placebo PROMITOR® dose 3 PROMITOR® (including Maltodextrin) Investigational product dose 3 PROMITOR® dose 2 PROMITOR® (including Maltodextrin) Investigational product dose 2
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Biofortis
🇫🇷Saint Herblain, France
Metabolic Unit, Clinical Development Unit Nestec
🇨🇭Lausanne, Switzerland