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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sofia Nordh, PhD
- 전화번호: +46 (0)8 555 293 00
- 이메일: son@biogaianewsciences.com
연구 장소
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Helsinki, 핀란드
- Helsinki University Hospital
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연락하다:
- Samuli Rautava, MD
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Tampere, 핀란드
- Tampere University Hospital
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연락하다:
- Sauli Palmu, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Probiotic+ Vitamin D3
C-section, active group
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Probiotic+vitamin D3 drops
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위약 비교기: Placebo+ Vitamin D3
C-section, placebo group
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Placebo+vitamin D3
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위약 비교기: Placebo+ Vitamin D3 open label group
Vaginal, placebo group
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Placebo+vitamin D3
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To assess early gut microbial colonization in C-section newborns after probiotic supplementation + vitamin D3 or placebo + vitamin D3 and in vaginal born controls.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To evaluate the gut microbiome colonization and composition.
기간: 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.
기간: 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.
기간: 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 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.
기간: 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 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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
기간: 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.
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- CSUB0198
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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