Prebiotic EffecT InfanTs

Last updated: April 11, 2023
Sponsor: Beneo-Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04791956
20018m-jhr
  • Ages 6-12
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on stool consistency in infants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Child is healthy at the time of pre-examination
  • Child was born on term or preterm (≥ 32 weeks of gestation)
  • Child is aged 6-12 months at the time of pre-examination (for preterm born children (32-37 weeks of gestation), corrected age will be applied)
  • Normal growth (weight and length for age between 10th and 90th percentiles, Fenton andKim 2013)
  • Child receives at least one meal per day as complementary feeding
  • Child and legal guardian are able and willing to follow the study instructions
  • Child is suitable for participation in the study according to theinvestigator/physician/study personnel
  • Written informed consent is given by parent or legal guardian

Exclusion

Exclusion Criteria:

  • No legal guardian's command of any local language
  • Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida,hypothyroidism etc.
  • Other metabolic or renal abnormalities or psychomotor retardation (e.g. hypotonia)
  • Child has allergy to cow's milk protein or lactose intolerance
  • Child has been or is currently breast-fed more than once daily (6 weeks beforeintervention)
  • Child has mostly loose or watery stools in ≥ 50% of defecations
  • Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks beforeintervention)
  • Use of laxatives or pre- or probiotic supplements in the previous 4 weeks beforeintervention
  • Child is currently involved or will be involved in another clinical or food study

Study Design

Total Participants: 140
Study Start date:
March 17, 2021
Estimated Completion Date:
June 30, 2024

Study Description

The fermentation of prebiotic inulin-type fructans leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA). The introduction of solid foods is frequently associated with harder stools which are more difficult to pass and can cause painful defecations. Subsequently, the changes in bowel habits associated with weaning and the introduction of complementary foods could be minimized by the addition of prebiotics to complementary foods and, thus, the transition from milk-feeding to family food could be facilitated.

Connect with a study center

  • Hospital Universitari Sant Joan de Reus - Magatzem

    Reus, 43204
    Spain

    Active - Recruiting

  • Hospital Universitari Joan XXIII de Tarragona - Almacén general

    Tarragona, 43005
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.