Biomarcadores de salud inmune y microbiota fecal en lactantes filipinos amamantados
Biomarcadores de salud inmunitaria y microbiota fecal en lactantes filipinos amamantados: un estudio observacional prospectivo
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Manila
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Manila, Manila, Filipinas, 1780
- Asian Hospital and Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
Inclusion Criteria:
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Written informed consent is obtained from parent(s)/ legally authorized representative(s) (LAR(s)).
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Parent(s)/ LAR(s) must be able to provide evidence of parental authority and identity.
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Parents/ LARs must understand the informed consent and other study documents.
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Infants whose parent(s)/ LAR (s) has consented to blood collection as per protocol.
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Able to temporarily store stool samples in a household freezer.
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Infants whose parent(s)/LAR(s) are willing and able to comply with scheduled visits, and the requirements of the study protocol.
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Infants whose parent(s)/LAR(s) can be contacted directly by telephone throughout the study.
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Infants must meet all the following inclusion criteria to be eligible for enrollment into the study:
- Healthy term infant (≥37 weeks of gestation)
- At enrollment visit, postnatal age ≥14 to ≤35 days (date of birth = day 0)
- Birth weight is appropriate for gestational age (i.e., ≥ 2500g and ≤ 4500g)
- Infant has exclusively received breastmilk from birth to enrollment, and parent intends to continue exclusive breastmilk feeding until infant age 6 months.
Exclusion Criteria:
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A medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
- Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
- Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
- 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.
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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.
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Infants whose parent(s) has(ve) not reached legal age of majority (18 years old) upon enrollment.
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Currently participating or having participated in any interventional clinical trials since birth.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Markers of systemic immunity
Periodo de tiempo: Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months and 12months
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fecal markers of immune health and gut barrier
Periodo de tiempo: Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12 months
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Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12 months
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Infant fecal microbiome
Periodo de tiempo: Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12months
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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
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Fecal metabolic profile and pH
Periodo de tiempo: Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12 months
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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
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Plasma Metabolomics
Periodo de tiempo: Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, and 12 months
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Untargeted Plasma metabolomics Analyses |
Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, and 12 months
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GI Tolerance
Periodo de tiempo: Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months
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Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months
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Weight
Periodo de tiempo: Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months
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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
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Length
Periodo de tiempo: Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months
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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
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Head circumference
Periodo de tiempo: Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months
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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
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Z-scores and percentiles
Periodo de tiempo: Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months.
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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.
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Infant illness and infection
Periodo de tiempo: Infant age 6 months
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Descriptive data and overall score derived from the Pediatric Immune System Index Questionnaire completed by parents |
Infant age 6 months
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Infant Complementary Food Intake
Periodo de tiempo: Infant age 6-12months
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Descriptive data from complementary food questionnaire and 3-day food record |
Infant age 6-12months
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Long-term infant illness (during the optional follow-up)
Periodo de tiempo: Infant age 12 months, 18 months, 24 months, 30 months, and 36 months
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Descriptive data from the Infant Illness Questionnaire completed by parents |
Infant age 12 months, 18 months, 24 months, 30 months, and 36 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Adverse Events
Periodo de tiempo: From infant age ≥14 to ≤35 days to 12 months
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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
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Concomitant medications and treatments
Periodo de tiempo: From infant age ≥14 to ≤35 days to 12 months
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Maria Rosario JK Capeding, MD, Asian Hospital and Medical Center, Philippines
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2313INF
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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