Lactobacillus Reuteri DSM 17938 in Gut Microbiota Development in Infant Born by Caesarean Section
NCT ID: NCT03675048
Last Updated: 2021-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
97 participants
INTERVENTIONAL
2018-10-01
2020-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intervention group
The intervention group will receive 5 drops (10\^8 cfu Lactobacillus reuteri DSM 17938) twice daily during feeding for 4 weeks.
BioGaia Protectis drops
food supplement containing the patented lactic acid bacterium Lactobacillus reuteri Protectis®/™ (L. reuteri DSM 17938).
Placebo group
The placebo group will receive 5 drops twice daily during feeding for 4 weeks. Placebo composition will be identical to that of the study drug but will not contain L. reuteri.
Placebo
Contains same excipients as study drug, without the active ingredient L. Reuteri.
Control group
The infants from the control group will comply with the same requirements and will undergo the same procedures as participants from the main group except for randomization and treatment.
No interventions assigned to this group
Interventions
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BioGaia Protectis drops
food supplement containing the patented lactic acid bacterium Lactobacillus reuteri Protectis®/™ (L. reuteri DSM 17938).
Placebo
Contains same excipients as study drug, without the active ingredient L. Reuteri.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age of enrolment is not more than 48 hours
* birth weight is corresponded to gestational age
* Apgar score ≥8 at 5 minutes
* Absence of congenital anomaly and/or clinical or physical abnormalities identified during clinical examination
* Primarily breastfeeding during the first days of life (more than 50%)
* Parent(s) are willing to comply with the exclusive breastfeeding regime during study period
* Parent(s) are willing to follow dietary recommendations during study period
* Parent(s) are willing to fill in the Diary every day
* Availability of the parent(s) and the infant during study period
* Written informed consent of the parent(s)
Exclusion Criteria
* Gastrointestinal tract diseases of mother or child
* Delay in development
* Congenital abnormalities
* Intake of antibiotics by mother orally and / or vaginally during the last trimester of pregnancy
* Intake of probiotics by mother during the last trimester of pregnancy
* Using of general anesthesia during Caesarean section
* Emergency Caesarean section
0 Hours
48 Hours
ALL
No
Sponsors
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BioGaia AB
INDUSTRY
Responsible Party
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Locations
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State Autonomous Healthcare Institution of the Moscow Region "Central clinical hospital of Khimki"
Khimki, Moscow Oblast, Russia
Countries
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Other Identifiers
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CSUB0142
Identifier Type: -
Identifier Source: org_study_id
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