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

29. April 2026 aktualisiert von: 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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Detaillierte Beschreibung

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

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

100

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Association between maternal HMO and infant gut Bifidobacterium
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Mitarbeiter

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

30. Juli 2025

Primärer Abschluss (Tatsächlich)

23. Oktober 2025

Studienabschluss (Geschätzt)

30. Mai 2026

Studienanmeldedaten

Zuerst eingereicht

29. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. April 2026

Zuerst gepostet (Tatsächlich)

6. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • UH25030200

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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