Fiber Tolerability in Children

N/ACompletedNCT02519374

Société des Produits Nestlé (SPN)40 enrolled

Overview

Assessment of the digestive tolerability of the PROMITOR® .

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Signs and Symptoms, Digestive

Interventions

Placebo (including Maltodextrin)DRUG

PROMITOR® (including Maltodextrin)DRUG

Investigational product dose 1

PROMITOR® (including Maltodextrin)DRUG

Investigational product dose 2

Eligibility

Sex: ALLMin age: 8 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (2)

Biofortis

Saint-Herblain, France

Metabolic Unit, Clinical Development Unit Nestec

Lausanne, Switzerland

Outcomes

Primary Outcomes

Assessment of the digestive tolerability of the Investigational Product (abdominal pain)

Using analog visual scale

Time frame: 7 days of intake

Assessment of the digestive tolerability of the Investigational Product (rumbling)

Using analog visual scale

Time frame: 7 days of intake

Assessment of the digestive tolerability of the Investigational Product (bloating)

Using analog visual scale

Time frame: 7 days of intake

Assessment of the digestive tolerability of the Investigational Product (flatulence)

Using analog visual scale

Time frame: 7 days of intake

Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency)

Using analog visual scale

Time frame: 7 days of intake

Data from ClinicalTrials.gov

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