Back to resultsLactobacillus Reuteri DSM 17938 in Gut Microbiota Development in Infant Born by Caesarean Section
Primary Purpose
Dysbiosis, Prophylaxis
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
BioGaia Protectis drops
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Dysbiosis focused on measuring Gut Microbiota, Cesarean Section, Dysbiosis
Eligibility Criteria
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
Sites / Locations
- State Autonomous Healthcare Institution of the Moscow Region "Central clinical hospital of Khimki"
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Intervention group
Placebo group
Control group
Arm Description
The intervention group will receive 5 drops (10^8 cfu Lactobacillus reuteri DSM 17938) twice daily during feeding for 4 weeks.
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.
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.
Outcomes
Primary Outcome Measures
Composition of gut microbiota in infants born by Caesarean section
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.
Secondary Outcome Measures
Composition of gut microbiota in infants born by vaginal delivery
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.
Composition of gut microbiota in infants born by vaginal delivery
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.
Composition of gut microbiota in infants born by Caesarean section
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.
Composition of gut microbiota in infants born by Caesarean section
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.
Composition of gut microbiota in infants born by vaginal delivery
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.
Composition of short-chain fatty acids (SCFA) in infants born by vaginal delivery
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.
Composition of short-chain fatty acids (SCFAs) in infants born by Caesarean section
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.
Adverse events assessment
Incidence of adverse events observed during usage of L. reuteri DSM 17938 in drop form.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03675048
Brief Title
Lactobacillus Reuteri DSM 17938 in Gut Microbiota Development in Infant Born by Caesarean Section
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 5, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioGaia AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysbiosis, Prophylaxis
Keywords
Gut Microbiota, Cesarean Section, Dysbiosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group will receive 5 drops (10^8 cfu Lactobacillus reuteri DSM 17938) twice daily during feeding for 4 weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
BioGaia Protectis drops
Other Intervention Name(s)
BioGaia® Probiotic. Drops for baby
Intervention Description
food supplement containing the patented lactic acid bacterium Lactobacillus reuteri Protectis®/™ (L. reuteri DSM 17938).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Contains same excipients as study drug, without the active ingredient L. Reuteri.
Primary Outcome Measure Information:
Title
Composition of gut microbiota in infants born by Caesarean section
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Composition of gut microbiota in infants born by vaginal delivery
Description
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.
Time Frame
14 days
Title
Composition of gut microbiota in infants born by vaginal delivery
Description
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.
Time Frame
30 days
Title
Composition of gut microbiota in infants born by Caesarean section
Description
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.
Time Frame
30 days
Title
Composition of gut microbiota in infants born by Caesarean section
Description
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.
Time Frame
112 days (16 weeks)
Title
Composition of gut microbiota in infants born by vaginal delivery
Description
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.
Time Frame
112 days (16 weeks)
Title
Composition of short-chain fatty acids (SCFA) in infants born by vaginal delivery
Description
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.
Time Frame
14 days
Title
Composition of short-chain fatty acids (SCFAs) in infants born by Caesarean section
Description
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.
Time Frame
14 days
Title
Adverse events assessment
Description
Incidence of adverse events observed during usage of L. reuteri DSM 17938 in drop form.
Time Frame
112 days (16 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Hours
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
State Autonomous Healthcare Institution of the Moscow Region "Central clinical hospital of Khimki"
City
Khimki
State/Province
Moscow Region
ZIP/Postal Code
141407
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Lactobacillus Reuteri DSM 17938 in Gut Microbiota Development in Infant Born by Caesarean Section
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