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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Sofia Nordh, PhD
- Numer telefonu: +46 (0)8 555 293 00
- E-mail: son@biogaianewsciences.com
Lokalizacje studiów
-
-
-
Helsinki, Finlandia
- Helsinki University Hospital
-
Kontakt:
- Samuli Rautava, MD
-
Tampere, Finlandia
- Tampere University Hospital
-
Kontakt:
- Sauli Palmu, MD
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Probiotic+ Vitamin D3
C-section, active group
|
Probiotic+vitamin D3 drops
|
|
Komparator placebo: Placebo+ Vitamin D3
C-section, placebo group
|
Placebo+vitamin D3
|
|
Komparator placebo: Placebo+ Vitamin D3 open label group
Vaginal, placebo group
|
Placebo+vitamin D3
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
To assess early gut microbial colonization in C-section newborns after probiotic supplementation + vitamin D3 or placebo + vitamin D3 and in vaginal born controls.
Ramy czasowe: week 2
|
To evaluate the faecal relative abundance of Actinobacteria in the gut microbiome
|
week 2
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
To evaluate the gut microbiome colonization and composition.
Ramy czasowe: week 2
|
To evaluate the faecal relative abundance of Bifidobacterium in gut microbiome
|
week 2
|
|
To evaluate the gut microbiome colonization and composition.
Ramy czasowe: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
To evaluate the faecal relative abundance and composition of Actinobacteria over time
|
Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
|
To evaluate the gut microbiome colonization and composition.
Ramy czasowe: 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
|
Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
|
To evaluate the gut microbiome colonization and composition.
Ramy czasowe: 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
|
Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
|
To evaluate the gut microbiome colonization and composition.
Ramy czasowe: 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 Enterobacteriaceae over time
|
Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
|
To evaluate the gut microbiome colonization and composition.
Ramy czasowe: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
|
To evaluate faecal relative abundance and composition of Bacillota over time
|
Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
|
|
To evaluate the gut microbiome colonization and composition.
Ramy czasowe: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
To evaluate faecal relative abundance of Limosilactobacillus reuteri over time
|
Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
|
|
To evaluate the gut microbiome colonization and composition.
Ramy czasowe: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
|
To evaluate gut microbial profiles (diversity, relative abundance, species alteration, function) in faecal samples among different groups of infants over time
|
Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
|
|
To assess quality of life
Ramy czasowe: Weeks 4 and 8, with optional assessments at 6 and 12 months.
|
To evaluate quality of life by Paediatric Quality of Life Inventory (PedsQL),
|
Weeks 4 and 8, with optional assessments at 6 and 12 months.
|
|
To assess quality of life.
Ramy czasowe: Weeks 2, 4 and 8, with optional assessments at 6 and 12 months and 3 years.
|
To evaluate symptoms of infant gastrointestinal distress by Infant Gastrointestinal symptoms questionnaire (IGSQ)
|
Weeks 2, 4 and 8, with optional assessments at 6 and 12 months and 3 years.
|
|
To assess quality of life
Ramy czasowe: Weeks 4 and 8, with optional assessments at 6 and 12 months.
|
To evaluate symptoms of infant sleep distress by Brief Infant Sleep Questionnaire (BISQ-R)
|
Weeks 4 and 8, with optional assessments at 6 and 12 months.
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- CSUB0198
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .