Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Biomarker für die Immungesundheit und fäkale Mikrobiota bei philippinischen gestillten Säuglingen

16. September 2026 aktualisiert von: Société des Produits Nestlé (SPN)

Biomarker für die Immungesundheit und fäkale Mikrobiota bei philippinischen gestillten Säuglingen: eine prospektive Beobachtungsstudie

This will be a prospective observational study aiming to investigate immune health biomarkers and fecal microbiota in 48-60 Filipino breastfed infants from birth to 12 months of age. An optional follow-up period of approximately 2 years will follow.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This will be a prospective observational study in healthy term infants who are exclusively breastfed. Approximately 48-60 healthy breastfed infants aged ≥14 to ≤35 days at enrollment will be recruited and followed up until 12 month of age at 6 on-site visits: V1 (baseline), V3 (2 months), V5 (4 months), V6 (6 month), V7 (10months) and V8 (12 months).

The 12-month observational period will be followed by a 2year optional follow-up period for a total duration of the study of approximately 3 years.

The primary objective of this clinical study is to characterize early immune system development in breastfed Filipino infants by investigating infant blood markers of systemic immunity.

The secondary objectives will include the characterization of infant fecal markers of immune health and gut barrier function, infant blood and fecal microbiome, interactions between immune development and microbiome maturation, infant fecal metabolic profile and fecal pH, infant gastrointestinal (GI) tolerance, infant anthropometric measurements, infant complementary food intake as well as infant illness and infection.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

60

Kontakte und Standorte

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

Studienorte

  • Philippinen
    • Manila
      • Manila, Manila, Philippinen, 1780
        • Asian Hospital and Medical Center

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

2 Wochen bis 1 Monat (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Approximately 60 healthy breastfed infants aged ≥14 to ≤35 days at enrollment. To ensure balanced sex representation of the study population, approximately 30 males and 30 females will be enrolled in the study.

Beschreibung

Inclusion Criteria:

  1. Written informed consent is obtained from parent(s)/ legally authorized representative(s) (LAR(s)).

  2. Parent(s)/ LAR(s) must be able to provide evidence of parental authority and identity.

  3. Parents/ LARs must understand the informed consent and other study documents.

  4. Infants whose parent(s)/ LAR (s) has consented to blood collection as per protocol.

  5. Able to temporarily store stool samples in a household freezer.

  6. Infants whose parent(s)/LAR(s) are willing and able to comply with scheduled visits, and the requirements of the study protocol.

  7. Infants whose parent(s)/LAR(s) can be contacted directly by telephone throughout the study.

  8. Infants must meet all the following inclusion criteria to be eligible for enrollment into the study:

    1. Healthy term infant (≥37 weeks of gestation)
    2. At enrollment visit, postnatal age ≥14 to ≤35 days (date of birth = day 0)
    3. Birth weight is appropriate for gestational age (i.e., ≥ 2500g and ≤ 4500g)
    4. Infant has exclusively received breastmilk from birth to enrollment, and parent intends to continue exclusive breastmilk feeding until infant age 6 months.

Exclusion Criteria:

  1. A medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:

    1. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
    2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
    3. Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the study. Of note, children who are normally healthy but at the time of enrolment suffering from acute illness in a minor condition which are common in childhood and do not require some of the exclusionary medication mentioned below can be enrolled.

  2. Presently receiving or have received prior to enrolment any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool microbiota and characteristics (e.g., oral, or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g., insulin or growth hormone); gastric acid secretion.

  3. Infants whose parent(s) has(ve) not reached legal age of majority (18 years old) upon enrollment.

  4. Currently participating or having participated in any interventional clinical trials since birth.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: OTHER
  • Zeitperspektiven: PROSPECTIVE

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Markers of systemic immunity
Zeitfenster: Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months and 12months

Descriptive statistics of plasma immune proteomics using mass cytometry or immunoassays, and vaccine-specific antibodies assessed by ELISA
Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months and 12months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Fecal markers of immune health and gut barrier
Zeitfenster: Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12 months
  • Fecal markers of immune health and gut barrier, such as but not restricted to calprotectin and α-1-antitrypsin assessed by ELISA or alternative methods
  • Fecal cytokine profile using multiplex assays
Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12 months
Infant fecal microbiome
Zeitfenster: Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12months

Microbiota composition, diversity, community types, and abundance of bacteria taxa
Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12months
Fecal metabolic profile and pH
Zeitfenster: Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12 months

pH and fecal organic acids, such as lactate, propionate, butyrate, acetate, valerate and total fecal organic acids, in wet stool weight and per dry stool weight
Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12 months
Plasma Metabolomics
Zeitfenster: Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, and 12 months

Untargeted Plasma metabolomics Analyses
Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, and 12 months
GI Tolerance
Zeitfenster: Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months
  • Stool frequency and consistency, GI symptoms and GI-related behaviors collected via 1-day and 3-day GI Symptom and Behavior Diaries
  • GI burden score derived from the Infant Gastrointestinal Symptom Questionnaire (IGSQ-13)
Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months
Weight
Zeitfenster: Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months

Measurement of weight in grams
Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months
Length
Zeitfenster: Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months

Measurement of length in cm
Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months
Head circumference
Zeitfenster: Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months

Measurement of head circumference in cm
Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months
Z-scores and percentiles
Zeitfenster: Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months.

Changes in weight-for-age, weight-for-length, length-for-age, BMI-for-age, and head-circumference-for-age z-scores and percentiles calculated according to WHO standards
Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months.
Infant illness and infection
Zeitfenster: Infant age 6 months

Descriptive data and overall score derived from the Pediatric Immune System Index Questionnaire completed by parents
Infant age 6 months
Infant Complementary Food Intake
Zeitfenster: Infant age 6-12months

Descriptive data from complementary food questionnaire and 3-day food record
Infant age 6-12months
Long-term infant illness (during the optional follow-up)
Zeitfenster: Infant age 12 months, 18 months, 24 months, 30 months, and 36 months

Descriptive data from the Infant Illness Questionnaire completed by parents
Infant age 12 months, 18 months, 24 months, 30 months, and 36 months

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Adverse Events
Zeitfenster: From infant age ≥14 to ≤35 days to 12 months

Incidents of adverse events from time of ICF signing at baseline, age ≥14 to ≤35 days, through the last study visit at age 12 months
From infant age ≥14 to ≤35 days to 12 months
Concomitant medications and treatments
Zeitfenster: From infant age ≥14 to ≤35 days to 12 months

All concomitant medications / treatments (including type and duration) used to treat illnesses and other conditions will be recorded continuously from time of ICF signing at baseline, age ≥14 to ≤35 days, through the last study visit at age 12 months
From infant age ≥14 to ≤35 days to 12 months

Mitarbeiter und Ermittler

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

Sponsor

Société des Produits Nestlé (SPN)

Mitarbeiter

Asian Hospital and Medical Center, Muntinlupa City, Philippines

Ermittler

  • Hauptermittler: Maria Rosario JK Capeding, MD, Asian Hospital and Medical Center, Philippines

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)

29. November 2024

Primärer Abschluss (Tatsächlich)

30. Januar 2026

Studienabschluss (Geschätzt)

31. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

5. November 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. November 2024

Zuerst gepostet (Tatsächlich)

27. November 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2313INF

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

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 .

Abonnieren