NCT03675048

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

September 14, 2018

Last Update Submit

September 14, 2021

Conditions

DysbiosisProphylaxis

Keywords

Gut MicrobiotaCesarean SectionDysbiosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Composition of gut microbiota in infants born by vaginal delivery

    14 days

  • Composition of gut microbiota in infants born by vaginal delivery

    30 days

  • Composition of gut microbiota in infants born by Caesarean section

    30 days

  • Composition of gut microbiota in infants born by Caesarean section

    112 days (16 weeks)

  • Composition of gut microbiota in infants born by vaginal delivery

    112 days (16 weeks)

  • +3 more secondary outcomes

Study Arms (3)

Intervention group

EXPERIMENTAL

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

Dietary Supplement: BioGaia Protectis drops

Placebo group

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Control group

NO INTERVENTION

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.

Interventions

BioGaia Protectis dropsDIETARY_SUPPLEMENT

food supplement containing the patented lactic acid bacterium Lactobacillus reuteri Protectis®/™ (L. reuteri DSM 17938).

Also known as: BioGaia® Probiotic. Drops for baby
Intervention group
PlaceboDIETARY_SUPPLEMENT

Contains same excipients as study drug, without the active ingredient L. Reuteri.

Placebo group

Eligibility Criteria

Age0 Hours - 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Autonomous Healthcare Institution of the Moscow Region "Central clinical hospital of Khimki"

Khimki, Moscow Oblast, 141407, Russia

Location

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 18, 2018

Study Start

October 1, 2018

Primary Completion

October 5, 2020

Study Completion

December 15, 2020

Last Updated

September 20, 2021

Record last verified: 2021-09

Locations

RU(1)