Fiber Tolerability in Children Aged 3-7 Year (Fiber - TIC)

Nestlé

Status: Completed

Conditions: Signs and Symptoms, Digestive

Treatments: Drug: Dose 1 - Promitor®; Drug: Placebo (including Maltodextrin); Drug: Dose 3 - Promitor®; Drug: Dose 2 - Promitor®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02677090

15.10.NRC

Details and patient eligibility

About

Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years old.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

36 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo (including Maltodextrin)

Dose 1 - Promitor®

Active Comparator group

Description:

Investigational product Dose 1

Treatment:

Drug: Dose 1 - Promitor®

Dose 2 - Promitor®

Active Comparator group

Description:

Investigational product Dose 2

Treatment:

Drug: Dose 2 - Promitor®

Dose 3 - Promitor®

Active Comparator group

Description:

Investigational product Dose 3

Treatment:

Drug: Dose 3 - Promitor®