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Completed

NCT Number: NCT02677090

Fiber Tolerability in Children Aged 3-7 Year

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

Completed

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Key information

Conditions

Signs and Symptoms, Digestive Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biofortis

Saint-Herblain, 44800, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy children
  • Aged between 3 and 7 years old
  • Acceptance of the taste of the product
  • Having breakfast on daily basis
  • Consent and/or assent received according to regulation
  • Informed consent of both parents/guardians (in respect with the French regulation)
  • Parents/guardians affiliated to a health insurance (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 (in respect with the French regulation)

Treatment and study plan

Placebo (including Maltodextrin)

Drug

Dose 1 - Promitor®

Drug

Dose 2 - Promitor®

Drug

Dose 3 - Promitor®

Drug

Primary outcomes

  1. Assessment of the digestive tolerability of the Investigational Product (abdominal pain) using analog visual scale

    Time frame: 7 days of intake

    Using analog visual scale

  2. Assessment of the digestive tolerability of the Investigational Product (rumbling) using analog visual scale

    Time frame: 7 days of intake

    Using analog visual scale

  3. Assessment of the digestive tolerability of the Investigational Product (bloating) using analog visual scale

    Time frame: 7 days of intake

    Using analog visual scale

  4. Assessment of the digestive tolerability of the Investigational Product (flatulence) using analog visual scale

    Time frame: 7 days of intake

    Using analog visual scale

  5. Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency) using analog visual scale

    Time frame: 7 days of intake

    Using analog visual scale

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Acronym: Fiber - TIC

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2016
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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