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

BioGaia

Status: Completed

Conditions: Dysbiosis; Prophylaxis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: BioGaia Protectis drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT03675048

CSUB0142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 3 patient groups, including a placebo group

Intervention group

Experimental group

Description:

The intervention group will receive 5 drops (10\^8 cfu Lactobacillus reuteri DSM 17938) twice daily during feeding for 4 weeks.

Treatment:

Dietary Supplement: BioGaia Protectis drops

Placebo group

Placebo Comparator group

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.

Treatment:

Dietary Supplement: Placebo

Control group

No Intervention group

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.