NCT06631937 HMOs on Infant Gut Microbiota Modulation and Development of the Immune System in Healthy Infants
| NCT ID | NCT06631937 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Healthy Infants |
| Study Type | INTERVENTIONAL |
| Enrollment | 334 participants |
| Start Date | 2024-11-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 334 participants in total. It began in 2024-11-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: • All infants which parents has decided mode of feeding Exclusion Criteria: * Premature birth
Contact & Investigator
Lars H Pedersen, Professor, PhD, MD
PRINCIPAL INVESTIGATOR
Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT06631937 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 28 Days, studying Healthy Infants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06631937 currently recruiting?
Yes, NCT06631937 is actively recruiting participants. Contact the research team at diahoe@clin.au.dk for enrollment information.
Where is the NCT06631937 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Aarhus, Denmark.
Who is sponsoring the NCT06631937 clinical trial?
NCT06631937 is sponsored by University of Aarhus. The principal investigator is Lars H Pedersen, Professor, PhD, MD at Aarhus University Hospital. The trial plans to enroll 334 participants.