Lactobacillus Reuteri DSM 17938 in Gut Microbiota Development in Infant Born by Caesarean Section

Dysbiosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03675048
• Other study ID #: CSUB0142
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 15, 2020

Study information

• Verified date: September 2021
• Source: BioGaia AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 15, 2020
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 48 Hours

Eligibility

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

Related Conditions & MeSH terms

• Dysbiosis
• Prophylaxis

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Russian Federation	State Autonomous Healthcare Institution of the Moscow Region "Central clinical hospital of Khimki"	Khimki	Moscow Region

Sponsors (1)

Lead Sponsor	Collaborator
BioGaia AB

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days
Secondary	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.	14 days
Secondary	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.	30 days
Secondary	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.	30 days
Secondary	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.	112 days (16 weeks)
Secondary	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.	112 days (16 weeks)
Secondary	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.	14 days
Secondary	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.	14 days
Secondary	Adverse events assessment	Incidence of adverse events observed during usage of L. reuteri DSM 17938 in drop form.	112 days (16 weeks)