Prebiotic Effects in Healthy Toddlers

NCT05783141 | Recruiting DMC

• 1 other identifier: 22006n-mpz
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Child Development; Diet, Healthy

Keywords

Microbiota; Prebiota; Child´s health

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (4)

• Beneficial colonization

  Stool sample collected at baseline and after 90 days intervention period

• Stool consistency

  Data collected continuously from enrollment until end of intervention (up to 90 days).

• Stool frequency

  Data collected continuously from enrollment until end of intervention (up to 90 days).

• Caretaker´s absenteeism from work

  Data collected continuously from enrollment until end of intervention (up to 90 days).

Study Arms (2)

Experimental formula group

EXPERIMENTAL

Follow-on formula supplemented with a novel prebiotic combination

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

Control formula group

PLACEBO COMPARATOR

Follow-on formula not supplemented

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

Interventions

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

Standard follow-on formula administered orally

Also known as: supplemented with prebiotics

Experimental formula group

Standard follow-on formula, randomly assigned to healthy toddlers DIETARY_SUPPLEMENT

Standard follow-on formula administered orally

Also known as: not supplemented with prebiotics

Control formula group

Eligibility Criteria

• Age: 10 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child is healthy at the time of pre-examination
• Child is aged between 10-36 months and attends a day care center for the duration of the intervention
• Child attends a daycare center at the time of pre examination for at least 50%.
• Child presents a normal defecation characteristic (according to Brussels Infant and Toddler Stool scale)
• Weight for height z-score \>-2 and \<2 SD based on Flemish growth charts
• 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/ study personnel
• Informed written consent given by parent / legal guardian

You may not qualify if:

• No legal guardian's command of any local language
• 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)
• Child is suffering from congenital or acquired immunodeficiency
• Food allergies or intolerances
• Child is currently breast-fed more than once daily
• Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
• 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.
• Child is suffering from an infection at the time of pre examination or previous 7 days
• Child is currently involved or will be involved in another clinical or food study
• Child is not suitable for participation in the study according to the study personnel´s opinion

Sponsors & Collaborators

• Beneo-Institute: lead
• Universitair Ziekenhuis Brussel: collaborator

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Interventions

Prebiotics

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Yvan Vandenplas, Prof.

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Koen Huysentruyt, Prof.

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephan Theis, Dr

CONTACT

+496359803287; Stephan.Theis@beneo.com

Maria Pudenz, Dr.

CONTACT

maria.pudenz@beneo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 24, 2023
• Study Start: October 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1)