Last updated: April 11, 2023
Sponsor: Beneo-Institute
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT04791956
20018m-jhr
Ages 6-12 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Hospital Universitari Sant Joan de Reus - Magatzem
Reus, 43204
SpainActive - Recruiting
Hospital Universitari Joan XXIII de Tarragona - Almacén general
Tarragona, 43005
SpainActive - Recruiting
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