Influence of Probiotics on Early Gut Microbial Colonization (STORKIE)
Influence of Probiotics on Early Gut Microbial Colonization, Safety and Tolerability in Infants Born by Caesarean Section
The goal of this clinical trial is to learn whether daily probiotic drops plus vitamin D3 can improve early gut microbiome colonization in healthy infants born by C-section. It will also assess safety and tolerability.
An intervention with probiotics + vitamin D3 will be compared to placebo + vitamin D3 in a double-blind, randomized design, and include an open-label vaginal-born reference group.
Participants will receive study drops daily for 8 weeks and provide stool samples at multiple time points and complete questionnaires/diaries. After the intervention period, there is an optional follow-up period for up to 3 years.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sofia Nordh, PhD
- Número de teléfono: +46 (0)8 555 293 00
- Correo electrónico: son@biogaianewsciences.com
Ubicaciones de estudio
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Helsinki, Finlandia
- Helsinki University Hospital
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Contacto:
- Samuli Rautava, MD
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Tampere, Finlandia
- Tampere University Hospital
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Contacto:
- Sauli Palmu, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Infant born by planned C-section or vaginal born infant
Gestational age at birth ≥ 37±0 weeks to <41 ±0 weeks
Infant Apgar score 7-10, (5 minutes after birth)
Intention to breastfeed the infant
Parents/legal guardians are >18 years
Parents/legal guardians have readiness and the opportunity to fill out a study diary, questionnaires and agree to collect biological samples
Parents/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator
Parents/legal guardians are willing and able to give written informed consent for their and their infants participation in the study
Exclusion Criteria:
>72 hours after birth when collecting the first faecal sample and given the first drops of study product
Infants classified as small for gestational age (SGA), defined as birth weight < -2 standard deviations (SD) for gestational age and sex according to national reference standards.
Infants with birth of congenital malformations or anomalies
Infants not able to feed adequately by oral means at the time of screening (i.e., requiring tube feeding)
Infants requiring care in neonatal unit
Disruption of amniotic membranes for >24 hours
Infants consuming probiotics, including in infant formula
Mothers use of antibiotics during the last 14 days of pregnancy prior to delivery
Participation in other clinical studies
Any other disease, condition, or circumstance that, in the investigator's opinion, may compromise the participant's safety, adherence to the protocol, or the interpretation of study results
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Probiotic+ Vitamin D3
C-section, active group
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Probiotic+vitamin D3 drops
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Comparador de placebos: Placebo+ Vitamin D3
C-section, placebo group
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Placebo+vitamin D3
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Comparador de placebos: Placebo+ Vitamin D3 open label group
Vaginal, placebo group
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Placebo+vitamin D3
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To assess early gut microbial colonization in C-section newborns after probiotic supplementation + vitamin D3 or placebo + vitamin D3 and in vaginal born controls.
Periodo de tiempo: week 2
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To evaluate the faecal relative abundance of Actinobacteria in the gut microbiome
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week 2
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To evaluate the gut microbiome colonization and composition.
Periodo de tiempo: week 2
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To evaluate the faecal relative abundance of Bifidobacterium in gut microbiome
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week 2
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To evaluate the gut microbiome colonization and composition.
Periodo de tiempo: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
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To evaluate the faecal relative abundance and composition of Actinobacteria over time
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Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
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To evaluate the gut microbiome colonization and composition.
Periodo de tiempo: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
To evaluate the faecal relative abundance of Bifidobacterium over time
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Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
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To evaluate the gut microbiome colonization and composition.
Periodo de tiempo: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
To evaluate faecal relative abundance and composition of Proteobacteria over time
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Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
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To evaluate the gut microbiome colonization and composition.
Periodo de tiempo: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
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To evaluate faecal relative abundance and composition of Enterobacteriaceae over time
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Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
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To evaluate the gut microbiome colonization and composition.
Periodo de tiempo: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
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To evaluate faecal relative abundance and composition of Bacillota over time
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Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
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To evaluate the gut microbiome colonization and composition.
Periodo de tiempo: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
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To evaluate faecal relative abundance of Limosilactobacillus reuteri over time
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Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
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To evaluate the gut microbiome colonization and composition.
Periodo de tiempo: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
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To evaluate gut microbial profiles (diversity, relative abundance, species alteration, function) in faecal samples among different groups of infants over time
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Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
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To assess quality of life
Periodo de tiempo: Weeks 4 and 8, with optional assessments at 6 and 12 months.
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To evaluate quality of life by Paediatric Quality of Life Inventory (PedsQL),
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Weeks 4 and 8, with optional assessments at 6 and 12 months.
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To assess quality of life.
Periodo de tiempo: Weeks 2, 4 and 8, with optional assessments at 6 and 12 months and 3 years.
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To evaluate symptoms of infant gastrointestinal distress by Infant Gastrointestinal symptoms questionnaire (IGSQ)
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Weeks 2, 4 and 8, with optional assessments at 6 and 12 months and 3 years.
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To assess quality of life
Periodo de tiempo: Weeks 4 and 8, with optional assessments at 6 and 12 months.
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To evaluate symptoms of infant sleep distress by Brief Infant Sleep Questionnaire (BISQ-R)
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Weeks 4 and 8, with optional assessments at 6 and 12 months.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
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
Otros números de identificación del estudio
- CSUB0198
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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