Child DevelopmentPrebiKidzNCT05783141
Prebiotic Effects in Healthy Toddlers
A study testing New prebiotic follow-on formula, randomly assigned to healthy toddlers and Standard follow-on formula, randomly assigned to healthy toddlers in people with Child Development and Diet, Healthy, run by Beneo-Institute at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 10 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Diet, Healthy
- What is being tested?
- New prebiotic follow-on formula, randomly assigned to healthy toddlers and Standard follow-on formula, randomly assigned to healthy toddlers
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Maria Pudenz, Dr. contact
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, 1090
Hanne Delcourt, MD, 02 474 95 69, hanne.delcourt@uzbrussel.be
Amy De Waele, Studiecoördinator, 02 474 95 69, amy.dewaele@uzbrussel.be
About this study
Official title: Double-blind, Randomized Placebo-controlled Trial Investigating Cumulative or Even Synergistic Effects of a Novel Prebiotic Combination in Healthy Toddlers
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.
Read the detailed 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.
- Conditions
- Child Development, Diet, Healthy
- Being tested
- New prebiotic follow-on formula, randomly assigned to healthy toddlers, Standard follow-on formula, randomly assigned to healthy toddlers
- Keywords
- Microbiota, Prebiota, Child´s health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New prebiotic follow-on formula, randomly assigned to healthy toddlersDietary supplement
Also called supplemented with prebiotics
Standard follow-on formula administered orally
Standard follow-on formula, randomly assigned to healthy toddlersDietary supplement
Also called not supplemented with prebiotics
Standard follow-on formula administered orally
| Study group | Role | What they receive |
|---|---|---|
| Experimental formula group | Experimental | Follow-on formula supplemented with a novel prebiotic combination Receives: Dietary Supplement: New prebiotic follow-on formula, randomly assigned to healthy toddlers |
| Control formula group | Placebo comparator | Follow-on formula not supplemented Receives: Dietary Supplement: Standard follow-on formula, randomly assigned to healthy toddlers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fever
Number of febrile days (peak temperature of forehead at least 38.0°C)
Measured: 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.
Measured: Data collected continuously from enrollment until end of intervention (up to 90 days).
Secondary outcomes (4)
Beneficial colonization
Changes in fecal microbiota by 16S rRNA Sequencing
Measured: Stool sample collected at baseline and after 90 days intervention period
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
Measured: Data collected continuously from enrollment until end of intervention (up to 90 days).
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
Measured: Data collected continuously from enrollment until end of intervention (up to 90 days).
Caretaker´s absenteeism from work
Number of work days missed by the parents
Measured: Data collected continuously from enrollment until end of intervention (up to 90 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Oct 2023
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beneo-Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitair Ziekenhuis Brussel
- Responsible party
- Sponsor
- Investigators
- Yvan Vandenplas, Prof., Principal investigator, Universitair Ziekenhuis BrusselKoen Huysentruyt, Prof., Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783141
- Sponsor's protocol ID
- 22006n-mpz
- Acronym
- PrebiKidz
- Status last verified
- Sep 2024
- First submitted
- 21 Feb 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized Placebo-controlled Trial Investigating Cumulative or Even Synergistic Effects of a Novel Prebiotic Combination in Healthy Toddlers
- ClinicalTrials.gov ID
- NCT05783141
- Acronym / sponsor ID
- PrebiKidz / 22006n-mpz
- Conditions
- Child Development, Diet, Healthy
- Keywords
- Microbiota, Prebiota, Child´s health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Beneo-InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Universitair Ziekenhuis Brussel
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental formula group | Experimental | Dietary Supplement: New prebiotic follow-on formula, randomly assigned to healthy toddlersFollow-on formula supplemented with a novel prebiotic combination |
| Control formula group | Placebo comparator | Dietary Supplement: Standard follow-on formula, randomly assigned to healthy toddlersFollow-on formula not supplemented |
Who may qualify
- Ages
- 10 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New prebiotic follow-on formula, randomly assigned to healthy toddlersAlso: supplemented with prebioticsStandard follow-on formula administered orally | Dietary supplement | Experimental formula group |
| Standard follow-on formula, randomly assigned to healthy toddlersAlso: not supplemented with prebioticsStandard follow-on formula administered orally | Dietary supplement | Control formula group |
Primary outcome
Fever
Time frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Number of febrile days (peak temperature of forehead at least 38.0°C)
Absenteeism
Time frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Number of days of child´s absence from day care center due to infectious episodes or antibiotic treatment.
4 secondary outcomes
Beneficial colonization
Time frame: Stool sample collected at baseline and after 90 days intervention period
Stool consistency
Time frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Stool frequency
Time frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Caretaker´s absenteeism from work
Time frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Pudenz, Dr. contact
Yvan Vandenplas, Prof. principal investigator
Universitair Ziekenhuis Brussel
Koen Huysentruyt, Prof. principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New prebiotic follow-on formula, randomly assigned to healthy toddlers and Standard follow-on formula, randomly assigned to healthy toddlers in people with Child Development and Diet, Healthy, run by Beneo-Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephan Theis, Dr (+496359803287, Stephan.Theis@beneo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fever (time frame: Data collected continuously from enrollment until end of intervention (up to 90 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.