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Immunsundhedsbiomarkører og fækal mikrobiota hos filippinske ammede spædbørn

16. september 2026 opdateret af: Société des Produits Nestlé (SPN)

Immunsundhedsbiomarkører og fækal mikrobiota hos filippinske ammede spædbørn: en prospektiv, observationsundersøgelse

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 uger til 1 måned (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: OTHER
  • Tidsperspektiver: PROSPECTIVE

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Markers of systemic immunity
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fecal markers of immune health and gut barrier
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Adverse Events
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Société des Produits Nestlé (SPN)

Samarbejdspartnere

Asian Hospital and Medical Center, Muntinlupa City, Philippines

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. november 2024

Primær færdiggørelse (Faktiske)

30. januar 2026

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

5. november 2024

Først indsendt, der opfyldte QC-kriterier

25. november 2024

Først opslået (Faktiske)

27. november 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2313INF

Plan for individuelle deltagerdata (IPD)

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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