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Human Milk Oligosaccharides, Gut Bifidobacterium, Vitamin D, and Infant Immunity (HMO-BIFIDI)

29 kwietnia 2026 zaktualizowane przez: Bahrul Fikri, Hasanuddin University

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:

  • 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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Szczegółowy opis

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:

  1. Univariate analysis (Used to describe basic data characteristics, in the form of frequency, mean value, standard deviation, and range)
  2. Bivariate analysis

    1. 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.
    2. 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

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

100

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • South Sulawesi
      • Makassar, South Sulawesi, Indonezja, 90245
        • Hasanuddin University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

Inclusion Criteria:

  1. 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.
  2. Infant Subjects :

    • All infants of mothers who meet the inclusion criteria

Exclusion Criteria:

  1. 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
  2. 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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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.
At enrollment (single time point, cross-sectional assessment)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Association between maternal HMO and infant gut Bifidobacterium
Ramy czasowe: At enrollment (single time point, cross-sectional assessment)
Association between maternal human milk oligosaccharide (secretor status and 2FL' level) and Bifidobacterium abundance in infant stool.
At enrollment (single time point, cross-sectional assessment)
Association between maternal HMO and infant vitamin D level
Ramy czasowe: At enrollment (single time point, cross-sectional assessment)
Association between maternal human milk oligosaccharide (secretor status and 2FL' level) and vitamin D level in infant serum.
At enrollment (single time point, cross-sectional assessment)
Association between maternal HMO and breast milk immune markers
Ramy czasowe: At enrollment (single time point, cross-sectional assessment)
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).
At enrollment (single time point, cross-sectional assessment)
Association between breast milk Bifidobacterium and infant gut microbiota
Ramy czasowe: At enrollment (single time point, cross-sectional assessment)
This outcome assesses the association between Bifidobacterium composition in breast milk and gut microbiota (Bifidobacterium) composition in infant stool samples.
At enrollment (single time point, cross-sectional assessment)
Association between breast milk Bifidobacterium and infant vitamin D level
Ramy czasowe: At enrollment (single time point, cross-sectional assessment)
This outcome assesses the association between Bifidobacterium composition in breast milk and vitamin D level in infant serum.
At enrollment (single time point, cross-sectional assessment)
Association between breast milk Bifidobacterium and breast milk immune marker
Ramy czasowe: At enrollment (single time point, cross-sectional assessment)
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).
At enrollment (single time point, cross-sectional assessment)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Współpracownicy

Śledczy

  • Główny śledczy: Bahrul Fikri, MD, Ph.D, Department of Pediatrics, Faculty of Medicine, Hasanuddin University
  • Dyrektor Studium: Andi Raisyiah Akrimah Imran, MD, MHA, Department of Public Health and Family Medicine, Faculty of Medicine, Hasanuddin University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

30 lipca 2025

Zakończenie podstawowe (Rzeczywisty)

23 października 2025

Ukończenie studiów (Szacowany)

30 maja 2026

Daty rejestracji na studia

Pierwszy przesłany

29 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

6 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 kwietnia 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • UH25030200

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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