Status:
UNKNOWN
Prebiotic EffecT InfanTs
Lead Sponsor:
Beneo-Institute
Collaborating Sponsors:
Hospital Universitari Sant Joan de Reus
Hospital de Tarragona Joan XXIII
Conditions:
Infant Development
Healthy
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on stool consistency in infants.
Detailed 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...
Eligibility Criteria
Inclusion
- 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 and Kim 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 the investigator/physician/study personnel
- Written informed consent is given by parent or legal guardian
Exclusion
- 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 before intervention)
- Child has mostly loose or watery stools in ≥ 50% of defecations
- Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
- Use of laxatives or pre- or probiotic supplements in the previous 4 weeks before intervention
- Child is currently involved or will be involved in another clinical or food study
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04791956
Start Date
March 17 2021
End Date
June 1 2024
Last Update
April 12 2023
Active Locations (2)
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1
Hospital Universitari Sant Joan de Reus - Magatzem
Reus, Spain, 43204
2
Hospital Universitari Joan XXIII de Tarragona - Almacén general
Tarragona, Spain, 43005