Clinical trial NCT02519374: Fiber Tolerability in Children
Official title: Fiber Tolerability in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Signs and Symptoms, Digestive
Keywords: Fiber tolerability
Children
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-08-10
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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)

Primary outcomes:
measure: Assessment of the digestive tolerability of the Investigational Product (abdominal pain)
timeFrame: 7 days of intake
measure: Assessment of the digestive tolerability of the Investigational Product (rumbling)
timeFrame: 7 days of intake
measure: Assessment of the digestive tolerability of the Investigational Product (bloating)
timeFrame: 7 days of intake
measure: Assessment of the digestive tolerability of the Investigational Product (flatulence)
timeFrame: 7 days of intake
measure: Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency)
timeFrame: 7 days of intake
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Herblain
country: France
facility: Biofortis
city: Lausanne
country: Switzerland
facility: Metabolic Unit, Clinical Development Unit Nestec
Study officials:
References: