Actively Recruiting
HMOs on Infant Gut Microbiota Modulation and Development of the Immune System in Healthy Infants
Led by University of Aarhus · Updated on 2024-11-12
334
Participants Needed
2
Research Sites
142 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
U
University of Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HMOs on Infant Gut Microbiota Modulation and Development of the Immune System in Healthy Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant's parents have decided the mode of feeding
You will not qualify if you...
- Premature birth
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Not Yet Recruiting
2
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
Research Team
D
Diana Høtoft
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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