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필리핀 모유수유아의 면역 건강 바이오마커와 분변 미생물군

2026년 9월 16일 업데이트: Société des Produits Nestlé (SPN)

필리핀 모유수유 유아의 면역 건강 바이오마커 및 분변 미생물군: 전향적 관찰 연구

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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (실제)

60

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 필리핀 제도
    • Manila
      • Manila, Manila, 필리핀 제도, 1780
        • Asian Hospital and Medical Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

2주 (어린이)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: OTHER
  • 시간 관점: PROSPECTIVE

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Markers of systemic immunity
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Fecal markers of immune health and gut barrier
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Incidence of Adverse Events
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Société des Produits Nestlé (SPN)

협력자

Asian Hospital and Medical Center, Muntinlupa City, Philippines

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 11월 29일

기본 완료 (실제)

2026년 1월 30일

연구 완료 (추정된)

2027년 12월 31일

연구 등록 날짜

최초 제출

2024년 11월 5일

QC 기준을 충족하는 최초 제출

2024년 11월 25일

처음 게시됨 (실제)

2024년 11월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 16일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2313INF

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아니요

약물 및 장치 정보, 연구 문서

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아니

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아니

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