Prebiotic Effects in Healthy Toddlers (PrebiKidz)

Beneo

Status: Enrolling

Conditions: Child Development; Diet, Healthy

Treatments: Dietary Supplement: Standard follow-on formula, randomly assigned to healthy toddlers; Dietary Supplement: New prebiotic follow-on formula, randomly assigned to healthy toddlers

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05783141

22006n-mpz

Details and patient eligibility

About

The aim of this study is to demonstrate that a dietary supplementation with a novel prebiotic combination is safe, well tolerated and able to improve overall health of toddlers.

Full description

The fermentation of a novel prebiotic combination 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 efficacy of the prebiotic combination to improve toddler's digestive function will be addressed. The overall health will be assessed as a measure of reduced number of febrile days resulting in less days of absenteeism from daycare centers.

Enrollment: 342 estimated patients

Sex: All

Ages: 10 to 36 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Child is healthy at the time of pre-examination
2. Child is aged between 10-36 months and attends a day care center for the duration of the intervention
3. Child attends a daycare center at the time of pre examination for at least 50%.
4. Child presents a normal defecation characteristic (according to Brussels Infant and Toddler Stool scale)
5. Weight for height z-score >-2 and <2 SD based on Flemish growth charts
6. Child and legal guardian are able and willing to follow the study instructions
7. Child is suitable for participation in the study according to the investigator/ study personnel
8. Informed written consent given by parent / legal guardian

Exclusion criteria

1. No legal guardian's command of any local language
2. Child with any chronic disorder or disease, e.g., defecation disorders (incl. Hirschsprung and celiac disease) metabolic or renal abnormalities as well as mental or psychomotor retardation (incl. child´s mental delay and hypotonia)
3. Child is suffering from congenital or acquired immunodeficiency
4. Food allergies or intolerances
5. Child is currently breast-fed more than once daily
6. Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
7. Use of laxatives (4 weeks before intervention) as well as probiotic and prebiotic food supplements. Follow-on formula with L. Reuteri and/or GOS/FOS/HMO is allowed.
8. Child is suffering from an infection at the time of pre examination or previous 7 days
9. Child is currently involved or will be involved in another clinical or food study
10. Child is not suitable for participation in the study according to the study personnel´s opinion

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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342 participants in 2 patient groups, including a placebo group

Experimental formula group

Experimental group

Description:

Follow-on formula supplemented with a novel prebiotic combination

Treatment:

Dietary Supplement: New prebiotic follow-on formula, randomly assigned to healthy toddlers

Control formula group

Placebo Comparator group

Description:

Follow-on formula not supplemented

Treatment:

Dietary Supplement: Standard follow-on formula, randomly assigned to healthy toddlers