Clinical trial NCT02677090: Fiber Tolerability in Children Aged 3-7 Year
Official title: Fiber Tolerability In Children Aged 3-7 Year
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: 2016-02-09
Enrollment: 36
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Assessment of the digestive tolerability of the Investigational Product (abdominal pain) using analog visual scale
timeFrame: 7 days of intake
measure: Assessment of the digestive tolerability of the Investigational Product (rumbling) using analog visual scale
timeFrame: 7 days of intake
measure: Assessment of the digestive tolerability of the Investigational Product (bloating) using analog visual scale
timeFrame: 7 days of intake
measure: Assessment of the digestive tolerability of the Investigational Product (flatulence) using analog visual scale
timeFrame: 7 days of intake
measure: Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency) using analog visual scale
timeFrame: 7 days of intake
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Herblain
country: France
facility: Biofortis
Study officials:
References: