Fiber Tolerability in Children

Signs and Symptoms, Digestive Clinical Trial

— FITIC  

Official title:

Fiber Tolerability in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519374
• Other study ID #: 14.29. NRC
• Status: Completed
• Phase: N/A
• First received: June 8, 2015
• Last updated: February 4, 2016
• Start date: June 2015
• Est. completion date: August 2015

Study information

• Verified date: July 2015
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Cantonal Office of Public Health
• Study type: Interventional

Clinical Trial Summary

Assessment of the digestive tolerability of the PROMITOR® .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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)

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)

• PROMITOR® (including Maltodextrin)
Investigational product dose 1
• PROMITOR® (including Maltodextrin)
Investigational product dose 2
• PROMITOR® (including Maltodextrin)
Investigational product dose 3

Locations

Country	Name	City	State
France	Biofortis	Saint Herblain
Switzerland	Metabolic Unit, Clinical Development Unit Nestec	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

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