Active — Not RecruitingNot Applicable

Human Milk Oligosaccharides, Gut Bifidobacterium, Vitamin D, and Infant Immunity

Indonesia100 participantsStarted 2025-07-30

Plain-language summary

The goal of this observational study is to learn how certain natural sugar components in breast milk may be linked with vitamin D level, healthy gut bacteria, and immune markers in healthy breastfed infants. The study will include exclusively breastfeeding mothers and their healthy infants aged 1 to 2 months. The main questions it aims to answer are: * Is this natural sugar in breast milk linked with the baby's vitamin D level? * Is this natural sugar in breast milk linked with healthy gut bacteria? * Is this baby's vitamin D level linked with healthy gut bacteria? * Is this natural sugar linked with immune factors in breast milk? Participants will answer health questions from questionnaire, undergo a brief physical examination, allow breast milk and a small baby blood sample to be collected, and provide an baby stool sample. Researchers will test these samples in the laboratory and analyze the results to answer the research questions.

Who can participate

Age range

1 Month

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Maternal Subject :
. Infant Subjects :

Exclusion criteria

. Maternal Subject :
. Infant Subjects:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Analysis maternal Human Milk Oligosaccharides (HMO) and Breast Milk (BM) Bifidobacterium and their correlation to gut Bifidobacterium, serum vitamin D and immune regulatory status in infants

Timeframe: At enrollment (single time point, cross-sectional assessment)

Trial details

NCT IDNCT07570329

SponsorHasanuddin University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-23

View on ClinicalTrials.gov More Healhty trials

Plain-language summary