Fiber Tolerability in Children Aged 3-7 Year

Signs and Symptoms, Digestive Clinical Trial

— Fiber - TIC  

Official title:

Fiber Tolerability In Children Aged 3-7 Year

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677090
• Other study ID #: 15.10.NRC
• Status: Completed
• Phase: N/A
• First received: January 29, 2016
• Last updated: March 9, 2016
• Start date: January 2016
• Est. completion date: March 2016

Study information

• Verified date: January 2016
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Signs and Symptoms
• Signs and Symptoms, Digestive

Intervention

Drug:
• Placebo (including Maltodextrin)

• Dose 1 - Promitor®

• Dose 2 - Promitor®

• Dose 3 - Promitor®

Locations

Country	Name	City	State
France	Biofortis	Saint Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the digestive tolerability of the Investigational Product (abdominal pain) using analog visual scale	Using analog visual scale	7 days of intake	No
Primary	Assessment of the digestive tolerability of the Investigational Product (rumbling) using analog visual scale	Using analog visual scale	7 days of intake	No
Primary	Assessment of the digestive tolerability of the Investigational Product (bloating) using analog visual scale	Using analog visual scale	7 days of intake	No
Primary	Assessment of the digestive tolerability of the Investigational Product (flatulence) using analog visual scale	Using analog visual scale	7 days of intake	No
Primary	Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency) using analog visual scale	Using analog visual scale	7 days of intake	No