Lactobacillus Reuteri DSM 17938 in Gut Microbiota Development in Infant Born by Caesarean Section
September 14, 2021 updated by: BioGaia AB
Single-center, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial on Estimating the Effect of Probiotic Strain Lactobacillus Reuteri DSM 17938 on Gut Microbiota Modulation in Infants Born by Caesarean Section
The aim of this study is to assess influence of probiotic Lactobacillus reuteri DSM 17938 on formation of gut microbiota in infant born by Caesarean section.
It is anticipated that daily using of probiotic Lactobacillus reuteri DSM 17938 can prevent development of early dysbiosis of gut microbiota induced by Caesarean section.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a single-center prospective randomized double-blind placebo-controlled clinical study.
The planned duration of the study for each included infant will be 16 weeks, 4 weeks of study drug intake and 12 weeks of follow-up.
140 healthy infants born by Caesarean section will be included in the general group of the study, and 60 healthy infants born by natural vaginal delivery will be included in the control group.
For infants included in the control group, all the same protocol requirements and procedures will be applied as for infants in the general group, except for randomization and the study product / placebo intake.
Infants included in the general study group will be randomly assigned into the study product / placebo subgroups in 1: 1 ratio.
During the study the gut microbiota will be analyzed.
Feces samples should be collected no later than 72 hours after birth, and also on 14th day of life ± 3 days, 30th day of life ± 3 days and 112th day of life ± 3 days.
Short-chain fatty acids (SCFA) will be analyzed in feces samples.
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Moscow Region
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Khimki, Moscow Region, Russian Federation, 141407
- State Autonomous Healthcare Institution of the Moscow Region "Central clinical hospital of Khimki"
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 2 days (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- gestational age more than 37 weeks and less than 41 weeks
- 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:
- Chronic diseases or serious health problems of mother or child
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention group
The intervention group will receive 5 drops (10^8 cfu Lactobacillus reuteri DSM 17938) twice daily during feeding for 4 weeks.
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food supplement containing the patented lactic acid bacterium Lactobacillus reuteri Protectis®/™ (L.
reuteri DSM 17938).
Other Names:
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Placebo Comparator: 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.
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Contains same excipients as study drug, without the active ingredient L. Reuteri.
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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composition of gut microbiota in infants born by Caesarean section
Time Frame: 14 days
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Composition of gut microbiota in infants born by Caesarean section in group received L. reuteri DSM 17938 versus placebo group at 14+/-3 day after delivery.
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14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Composition of gut microbiota in infants born by vaginal delivery
Time Frame: 14 days
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Composition of gut microbiota in infants born by vaginal delivery in comparison with infants born by Caesarean section and received L. reuteri DSM 17938 at 14+/-3 day after delivery.
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14 days
|
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Composition of gut microbiota in infants born by vaginal delivery
Time Frame: 30 days
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Composition of gut microbiota in infants born by vaginal delivery in comparison with infants born by Caesarean section and received L. reuteri DSM 17938 at 30+/-3 day after delivery.
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30 days
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Composition of gut microbiota in infants born by Caesarean section
Time Frame: 30 days
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Composition of gut microbiota in infants born by Caesarean section in group received L. reuteri DSM 17938 versus placebo group at 30+/-3 day after delivery.
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30 days
|
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Composition of gut microbiota in infants born by Caesarean section
Time Frame: 112 days (16 weeks)
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Composition of gut microbiota in infants born by Caesarean section in group received L. reuteri DSM 17938 versus placebo group at 112+/-3 day (16 weeks) after delivery.
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112 days (16 weeks)
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Composition of gut microbiota in infants born by vaginal delivery
Time Frame: 112 days (16 weeks)
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Composition of gut microbiota in infants born by vaginal delivery in comparison with infants born by Caesarean section and received L. reuteri DSM 17938 at 112+/-3 day (16 weeks) after delivery.
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112 days (16 weeks)
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Composition of short-chain fatty acids (SCFA) in infants born by vaginal delivery
Time Frame: 14 days
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Composition of short-chain fatty acids in infants born by vaginal delivery in comparison with infants born by Caesarean section and received L. reuteri DSM 17938 at 14+/-3 day after delivery.
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14 days
|
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Composition of short-chain fatty acids (SCFAs) in infants born by Caesarean section
Time Frame: 14 days
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Composition of short-chain fatty acids in infants born by Caesarean section in group received L. reuteri DSM 17938 versus placebo group at 14+/-3 day after delivery.
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14 days
|
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Adverse events assessment
Time Frame: 112 days (16 weeks)
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Incidence of adverse events observed during usage of L. reuteri DSM 17938 in drop form.
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112 days (16 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
October 5, 2020
Study Completion (Actual)
December 15, 2020
Study Registration Dates
First Submitted
September 14, 2018
First Submitted That Met QC Criteria
September 17, 2018
First Posted (Actual)
September 18, 2018
Study Record Updates
Last Update Posted (Actual)
September 20, 2021
Last Update Submitted That Met QC Criteria
September 14, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSUB0142
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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