Prebiotic Effects in Healthy Toddlers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Child Development Diet, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental formula group

Follow-on formula supplemented with a novel prebiotic combination

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Standard follow-on formula administered orally

Control formula group

Follow-on formula not supplemented

Group Type PLACEBO_COMPARATOR

Standard follow-on formula, randomly assigned to healthy toddlers

Intervention Type DIETARY_SUPPLEMENT

Standard follow-on formula administered orally

Interventions

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

Standard follow-on formula administered orally

Intervention Type DIETARY_SUPPLEMENT

Standard follow-on formula, randomly assigned to healthy toddlers

Standard follow-on formula administered orally

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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supplemented with prebiotics not supplemented with prebiotics

Eligibility Criteria

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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

Minimum Eligible Age

10 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes