HealhtyHMO-BIFIDINCT07570329
Human Milk Oligosaccharides, Gut Bifidobacterium, Vitamin D, and Infant Immunity
An observational study of Healhty, run by Hasanuddin University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month and olderHealthy volunteers can take part
- Conditions the study is for
- Healhty
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Jul 2025to 30 May 2026
- Phase
- Observational
- 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 1 month and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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 :
- All infants of mothers who meet the inclusion criteria
Who cannot join
- 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:
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Milk Oligosaccharides in Breast Milk and Its Relation to Gut Bifidobacterium, Vitamin D and Immune Modulation in Infants
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:
Read more
- 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.
Read the detailed description
Subject recruitment was conducted during immunization activities at community health centers (Puskesmas) and integrated health posts (Posyandu). The subject collection technique used the quota sampling method, a non-probability subject selection technique carried out by determining the desired sample size (quota) from a population with predetermined criteria, and researchers collected sample units until the target quota was reached. Researchers provided an explanation of the research protocol and obtained informed consent from participants regarding their willingness to participate in the study. Participants who met the eligibility criteria (inclusion and exclusion criteria) were declared as research subjects. Next, a research questionnaire was completed, including recording the subject's identity (mother and baby), the mother's health and nutritional history, childbirth and breastfeeding history, observation of the baby's stool, history and risk factors for allergies, and a general physical examination.
Mature breast milk samples will be analyzed to determine maternal secretion status, HMO status, Bifidobacterium in breast milk, and the status of immune markers such as sCD14, TGF-beta, and IgA in breast milk. Stool samples will be analyzed to determine the infant's intestinal Bifidobacterium. Blood samples will also be analyzed to determine vitamin D levels. Statistical correlations between these parameters will be performed to determine the research objectives.
The collected data is grouped based on the purpose and type of data, then the appropriate statistical method is selected, namely:
- Univariate analysis (Used to describe basic data characteristics, in the form of frequency, mean value, standard deviation, and range)
- Bivariate analysis
- Comparison Test (To see differences between groups)
- Chi-Square Test → If the variable is categorical (e.g., the relationship between maternal secretory status (Secretory vs. Non-Secretory) and delivery method (Vaginal vs. Cesarean section). An alternative test, the Fisher's Exact test, is performed if the basic assumptions of the Chi-Square are not met.
- T-Test (Independent T-Test) → If you want to compare the means of two groups (e.g., the difference in vitamin D levels between male and female infants). An alternative test, the Mann-Whitney test, is used if the data is not normally distributed.
- ANOVA Test → If you want to compare the means of more than two groups (e.g., the difference in vitamin D levels based on the timing of early breastfeeding initiation: <1 hour, 1-6 hours, >6 hours). An alternative test, the Kruskal-Wallis test, is used if the data is not normally distributed.
- Correlation Analysis (To see the relationship between two numeric variables)
- Pearson Correlation → If the data is normally distributed.
- Spearman Correlation → If the data is not normally distributed or is ordinal
- Conditions
- Healhty
- Keywords
- HMO, Vitamin D, Gut microbiota, Breast milk, Bifidobacterium, Immune modulation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment (single time point, cross-sectional assessment)
Secondary outcomes (6)
Association between maternal HMO and infant gut Bifidobacterium
Association between maternal human milk oligosaccharide (secretor status and 2FL' level) and Bifidobacterium abundance in infant stool.
Measured: At enrollment (single time point, cross-sectional assessment)
Association between maternal HMO and infant vitamin D level
Association between maternal human milk oligosaccharide (secretor status and 2FL' level) and vitamin D level in infant serum.
Measured: At enrollment (single time point, cross-sectional assessment)
Association between maternal HMO and breast milk immune markers
This outcome assesses the association between human milk oligosaccharide (HMO) (secretor status and 2FL' level) in breast milk and immune markers in breast milk, including soluble CD14 (sCD14), transforming growth factor beta (TGF-beta), and immunoglobulin A (IgA).
Measured: At enrollment (single time point, cross-sectional assessment)
Association between breast milk Bifidobacterium and infant gut microbiota
This outcome assesses the association between Bifidobacterium composition in breast milk and gut microbiota (Bifidobacterium) composition in infant stool samples.
Measured: At enrollment (single time point, cross-sectional assessment)
Association between breast milk Bifidobacterium and infant vitamin D level
This outcome assesses the association between Bifidobacterium composition in breast milk and vitamin D level in infant serum.
Measured: At enrollment (single time point, cross-sectional assessment)
Association between breast milk Bifidobacterium and breast milk immune marker
This outcome assesses the association between Bifidobacterium composition in breast milk and immune markers in breast milk, including soluble CD14 (sCD14), transforming growth factor beta (TGF-beta), and immunoglobulin A (IgA).
Measured: At enrollment (single time point, cross-sectional assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start30 Jul 2025
- Primary completion23 Oct 2025
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealhtyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Bahrul Fikri, Hasanuddin University
- Investigators
- Bahrul Fikri, MD, Ph.D, Principal investigator, Department of Pediatrics, Faculty of Medicine, Hasanuddin UniversityAndi Raisyiah Akrimah Imran, MD, MHA, Study director, Department of Public Health and Family Medicine, Faculty of Medicine, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570329
- Sponsor's protocol ID
- UH25030200
- Acronym
- HMO-BIFIDI
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be made publicly available. The study is supported by commercial funding from DSM-Firmenich, and participant-level data are subject to confidentiality and data-sharing restrictions under the research collaboration agreement. Any data access or sharing would require prior written approval from DSM-Firmenich and must comply with applicable ethical and regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Milk Oligosaccharides in Breast Milk and Its Relation to Gut Bifidobacterium, Vitamin D and Immune Modulation in Infants
- ClinicalTrials.gov ID
- NCT07570329
- Acronym / sponsor ID
- HMO-BIFIDI / UH25030200
- Conditions
- Healhty
- Keywords
- HMO, Vitamin D, Gut microbiota, Breast milk, Bifidobacterium, Immune modulation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 6 May 2026 (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 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.
Detailed description
Subject recruitment was conducted during immunization activities at community health centers (Puskesmas) and integrated health posts (Posyandu). The subject collection technique used the quota sampling method, a non-probability subject selection technique carried out by determining the desired sample size (quota) from a population with predetermined criteria, and researchers collected sample units until the target quota was reached. Researchers provided an explanation of the research protocol and obtained informed consent from participants regarding their willingness to participate in the study. Participants who met the eligibility criteria (inclusion and exclusion criteria) were declared as research subjects. Next, a research questionnaire was completed, including recording the subject's identity (mother and baby), the mother's health and nutritional history, childbirth and breastfeeding history, observation of the baby's stool, history and risk factors for allergies, and a general physical examination.
Mature breast milk samples will be analyzed to determine maternal secretion status, HMO status, Bifidobacterium in breast milk, and the status of immune markers such as sCD14, TGF-beta, and IgA in breast milk. Stool samples will be analyzed to determine the infant's intestinal Bifidobacterium. Blood samples will also be analyzed to determine vitamin D levels. Statistical correlations between these parameters will be performed to determine the research objectives.
The collected data is grouped based on the purpose and type of data, then the appropriate statistical method is selected, namely:
- Univariate analysis (Used to describe basic data characteristics, in the form of frequency, mean value, standard deviation, and range)
- Bivariate analysis
- Comparison Test (To see differences between groups)
- Chi-Square Test → If the variable is categorical (e.g., the relationship between maternal secretory status (Secretory vs. Non-Secretory) and delivery method (Vaginal vs. Cesarean section). An alternative test, the Fisher's Exact test, is performed if the basic assumptions of the Chi-Square are not met.
- T-Test (Independent T-Test) → If you want to compare the means of two groups (e.g., the difference in vitamin D levels between male and female infants). An alternative test, the Mann-Whitney test, is used if the data is not normally distributed.
- ANOVA Test → If you want to compare the means of more than two groups (e.g., the difference in vitamin D levels based on the timing of early breastfeeding initiation: <1 hour, 1-6 hours, >6 hours). An alternative test, the Kruskal-Wallis test, is used if the data is not normally distributed.
- Correlation Analysis (To see the relationship between two numeric variables)
- Pearson Correlation → If the data is normally distributed.
- Spearman Correlation → If the data is not normally distributed or is ordinal
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- Maternal Subject :
- Infant Subjects :
Key exclusion criteria (9 listed)
- Maternal Subject :
- Infant Subjects:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: At enrollment (single time point, cross-sectional assessment)
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.
6 secondary outcomes
Association between maternal HMO and infant gut Bifidobacterium
Time frame: At enrollment (single time point, cross-sectional assessment)
Association between maternal HMO and infant vitamin D level
Time frame: At enrollment (single time point, cross-sectional assessment)
Association between maternal HMO and breast milk immune markers
Time frame: At enrollment (single time point, cross-sectional assessment)
Association between breast milk Bifidobacterium and infant gut microbiota
Time frame: At enrollment (single time point, cross-sectional assessment)
Association between breast milk Bifidobacterium and infant vitamin D level
Time frame: At enrollment (single time point, cross-sectional assessment)
Association between breast milk Bifidobacterium and breast milk immune marker
Time frame: At enrollment (single time point, cross-sectional assessment)
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 6 May 2026.
- Individual participant dataSharing planned: No. No individual participant data will be made publicly available. The study is supported by commercial funding from DSM-Firmenich, and participant-level data are subject to confidentiality and data-sharing restrictions under the research collaboration agreement. Any data access or sharing would require prior written approval from DSM-Firmenich and must comply with applicable ethical and regulatory requirements.
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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. This study is not recruiting at the moment.
Bahrul Fikri, MD, Ph.D principal investigator
Department of Pediatrics, Faculty of Medicine, Hasanuddin University
Andi Raisyiah Akrimah Imran, MD, MHA study director
Department of Public Health and Family Medicine, Faculty of Medicine, Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healhty, run by Hasanuddin University at 1 site in Indonesia.
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 7 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: At enrollment (single time point, cross-sectional assessment)). 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 6 May 2026.