Prebiotic Effects in Healthy Toddlers

Child Development Clinical Trial

— PrebiKidz  

Official title:

Double-blind, Randomized Placebo-controlled Trial Investigating Cumulative or Even Synergistic Effects of a Novel Prebiotic Combination in Healthy Toddlers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05783141
• Other study ID #: 22006n-mpz
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: September 2025

Study information

• Verified date: July 2023
• Source: Beneo-Institute
• Contact: Stephan Theis, Dr
• Phone: +496359803287
• Email: Stephan.Theis[@]beneo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 342
• Est. completion date: September 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Diet, Healthy

Intervention

Dietary Supplement:
• New prebiotic follow-on formula, randomly assigned to healthy toddlers
Standard follow-on formula administered orally
• Standard follow-on formula, randomly assigned to healthy toddlers
Standard follow-on formula administered orally

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beneo-Institute	Universitair Ziekenhuis Brussel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fever	Number of febrile days (peak temperature of forehead at least 38.0°C)	Data collected continuously from enrollment until end of intervention (up to 90 days).
Primary	Absenteeism	Number of days of child´s absence from day care center due to infectious episodes or antibiotic treatment.	Data collected continuously from enrollment until end of intervention (up to 90 days).
Secondary	Beneficial colonization	Changes in fecal microbiota by 16S rRNA Sequencing	Stool sample collected at baseline and after 90 days intervention period
Secondary	Stool consistency	Hard, formed, soft and watery stools will be assessed by the parents and day care centers in a continuous daily bowel diary using the Brussels Infant and Toddler Stool Scale	Data collected continuously from enrollment until end of intervention (up to 90 days).
Secondary	Stool frequency	Number of defecations will be assessed by the parents and day care centers in a continuous daily bowel diary using the Brussels Infant and Toddler Stool Scale	Data collected continuously from enrollment until end of intervention (up to 90 days).
Secondary	Caretaker´s absenteeism from work	Number of work days missed by the parents	Data collected continuously from enrollment until end of intervention (up to 90 days).