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

NCT07570329 | Active Not Recruiting

• 1 other identifier: UH25030200
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healhty

Keywords

HMO; Vitamin D; Gut microbiota; Breast milk; Bifidobacterium; Immune modulation

Outcome Measures

Primary Outcomes (1)

• 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

  This outcome analyze the correlation between maternal human milk oligosaccharide (secretor status, 2FL' level), Breast Milk (BM) Bifidobacterium, gut Bifidobacterium, serum vitamin D and immune regulatory status in infants in infants aged 1 to 2 months.

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

Secondary Outcomes (6)

• Association between maternal HMO and infant gut Bifidobacterium

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

• Association between maternal HMO and infant vitamin D level

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

• Association between maternal HMO and breast milk immune markers

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

• Association between breast milk Bifidobacterium and infant gut microbiota

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

• Association between breast milk Bifidobacterium and infant vitamin D level

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

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population in this study was a group of breastfeeding mothers and their babies who came to visit immunization activities at integrated health posts/community health centers in Makassar City, Indonesia

You may qualify if:

• Maternal Subject :
• Women aged at least 18 years who are physically healthy;
• Have a healthy baby aged 1-2 months with a full-term gestational age (37-42 weeks) and a normal birth weight (2500-4000 grams);
• Exclusively breastfeeding;
• Agree to participate in this study by signing an informed consent form.
• Infant Subjects :

You may not qualify if:

• Maternal Subject :
• Currently participating in another clinical trial;
• Having a condition such as a breast abscess or other breast pathology;
• Currently taking medications for conditions that may affect breast milk, such as antibiotics;
• Subjects who cannot comply with the study protocol
• Infant Subjects:
• Currently participating in another clinical trial;
• Having a history of antimicrobial treatment (oral or parenteral antibiotics);
• Subjects are unable to comply with the research protocol.

Sponsors & Collaborators

• Hasanuddin University: lead
• DSM-Firmenich AG: collaborator

Study Sites (1)

Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Breast milk, blood, feces

Study Officials

• Bahrul Fikri, MD, Ph.D

  Department of Pediatrics, Faculty of Medicine, Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Andi Raisyiah Akrimah Imran, MD, MHA

  Department of Public Health and Family Medicine, Faculty of Medicine, Hasanuddin University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer and Pediatrician, Department of Pediatrics, Faculty of Medicine, Hasanuddin University

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: July 30, 2025
• Primary Completion: October 23, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)