Healthy InfantsBELIEFNCT06631937
HMOs on Infant Gut Microbiota Modulation and Development of the Immune System in Healthy Infants
A study testing Human Milk Oligosaccharides in people with Healthy Infants, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The goal of this clinical trial is to learn how a mixture of human milk oligosaccharides impacts the development of the infant microbiota, the immune maturation and how the interaction between the microbiota and immune maturation may impact both short and long term health of the infant. Read more about this study
- Who is it for?
- Ages 0 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Human Milk Oligosaccharides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 2 sitesDenmark
- Study dates
- 5 Nov 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All infants which parents has decided mode of feeding
Who cannot join
- Premature birth
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aarhus University Hospital
Aarhus, 8200
- Recruiting
Aarhus University Hospital
Aarhus
Diana Høtoft, +4523486730, diahoe@clin.au.dk
About this study
Official title: The Effect of Human Milk Oligosaccharides on Infant Gut Microbiota Modulation, Development of the Immune System and Health Later in Life: the BELIEF Study
The goal of this clinical trial is to learn how a mixture of human milk oligosaccharides impacts the development of the infant microbiota, the immune maturation and how the interaction between the microbiota and immune maturation may impact both short and long term health of the infant.
The participants will:
Read more
- Consume the investigational products (active/placebo) for 6 months
- Legal guardians/parents to the participant to collect stool samples from the diapers at home
- Legal guardians/parents to the participant to report gastrointestinal symptoms, signs of infections in an electronic questionnaire
- Visit the clinic for checkups and dried blood sample collection
For reference, a group of breastfed infants will be included. They will undergo the same procedures apart from consuming the investigational product (active/placebo). 230 participants (115 in each intervention arm) will be randomized to an intervention and 104 participants will be recruited for the reference group, giving a total sample size of 334 participants.
The intervention trial will be reported in two steps, first step covering the intervention phase from birth to 6 months; and step two includes both the intervention phase (0-6 months) and the follow-up period from 6-12 months. Informed consents for the possibility to preform long-term follow-up will be obtained.
- Conditions
- Healthy Infants
- Being tested
- Human Milk Oligosaccharides, Placebo
- Keywords
- infants, gastrointestinal microbiome, immune development, gastrointestinal well-being, infant formula fed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Milk OligosaccharidesOther
Human Milk Oligosaccharides provided in a commercially available infant formula powder, fed daily ad libitum from enrollement to 6 months of age
PlaceboOther
An identical commercially available infant formula powder without Human Milk Oligosaccharides, fed daily ad libitum from enrollement to 6 months of age
| Study group | Role | What they receive |
|---|---|---|
| Human Milk Oligosaccharides | Experimental | Human Milk Oligosaccharides (HMO) Receives: Other: Human Milk Oligosaccharides |
| Placebo | Placebo comparator | Identical commercial Infant Formula without human milk oligosaccharides, fed daily ad libitum from enrollement to 6 months of age Receives: Other: Placebo |
| Breastfed reference group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total abundance of bifidobacteria at 3 months of age
Abundance of fecal bifidobacteria measured by quantitative PCR
Measured: Fecal samples collected at 3 months
Secondary outcomes (1)
Infant fecal pH at 3 months of age
Fecal pH measured in fecal water at 3 months of age
Measured: Fecal samples collected at 3 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start5 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, placebo controlled trial of term infants with a 6 months intervention phase and 6 months short-term follow-up phase.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Technical University of Denmark, Chr Hansen
- Responsible party
- Sponsor
- Investigators
- Lars H Pedersen, Professor, PhD, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631937
- Sponsor's protocol ID
- HND-IN-054
- Acronym
- BELIEF
- Status last verified
- Nov 2024
- First submitted
- 20 Sep 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Human Milk Oligosaccharides on Infant Gut Microbiota Modulation, Development of the Immune System and Health Later in Life: the BELIEF Study
- ClinicalTrials.gov ID
- NCT06631937
- Acronym / sponsor ID
- BELIEF / HND-IN-054
- Conditions
- Healthy Infants
- Keywords
- infants, gastrointestinal microbiome, immune development, gastrointestinal well-being, infant formula fed
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Copenhagen, Technical University of Denmark, Chr Hansen
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 8 Oct 2024 (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 goal of this clinical trial is to learn how a mixture of human milk oligosaccharides impacts the development of the infant microbiota, the immune maturation and how the interaction between the microbiota and immune maturation may impact both short and long term health of the infant.
The participants will:
- Consume the investigational products (active/placebo) for 6 months
- Legal guardians/parents to the participant to collect stool samples from the diapers at home
- Legal guardians/parents to the participant to report gastrointestinal symptoms, signs of infections in an electronic questionnaire
- Visit the clinic for checkups and dried blood sample collection
For reference, a group of breastfed infants will be included. They will undergo the same procedures apart from consuming the investigational product (active/placebo). 230 participants (115 in each intervention arm) will be randomized to an intervention and 104 participants will be recruited for the reference group, giving a total sample size of 334 participants.
The intervention trial will be reported in two steps, first step covering the intervention phase from birth to 6 months; and step two includes both the intervention phase (0-6 months) and the follow-up period from 6-12 months. Informed consents for the possibility to preform long-term follow-up will be obtained.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized, placebo controlled trial of term infants with a 6 months intervention phase and 6 months short-term follow-up phase.
| Arm | Type | Receives |
|---|---|---|
| Human Milk Oligosaccharides | Experimental | Other: Human Milk OligosaccharidesHuman Milk Oligosaccharides (HMO) |
| Placebo | Placebo comparator | Other: PlaceboIdentical commercial Infant Formula without human milk oligosaccharides, fed daily ad libitum from enrollement to 6 months of age |
| Breastfed reference group | No intervention | – |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All infants which parents has decided mode of feeding
Key exclusion criteria (1 listed)
- Premature birth
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 |
|---|---|---|
| Human Milk OligosaccharidesHuman Milk Oligosaccharides provided in a commercially available infant formula powder, fed daily ad libitum from enrollement to 6 months of age | Other | Human Milk Oligosaccharides |
| PlaceboAn identical commercially available infant formula powder without Human Milk Oligosaccharides, fed daily ad libitum from enrollement to 6 months of age | Other | Placebo |
Primary outcome
Total abundance of bifidobacteria at 3 months of age
Time frame: Fecal samples collected at 3 months
Abundance of fecal bifidobacteria measured by quantitative PCR
1 secondary outcome
Infant fecal pH at 3 months of age
Time frame: Fecal samples collected at 3 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy Infants
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
Active, not recruiting
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
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.
Lars H Pedersen, Professor, PhD, MD principal investigator
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Milk Oligosaccharides in people with Healthy Infants, run by University of Aarhus at 2 sites in Denmark.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Høtoft (+4523486730, diahoe@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total abundance of bifidobacteria at 3 months of age (time frame: Fecal samples collected at 3 months). 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 12 Nov 2024.