Lactobacillus Reuteri Feasibility Study on Probiotic Treatment and Perinatal Microbiome

Summary

Investigators want to investigate if the Lactobacillus Reuteri (probiotic bacteria) given to pregnant women can be found in different maternal compartments and in the first stool and oral swab collected immediately after birth of a newborn delivered by cesarean delivery. Investigators also want to explore if exposure to this Lactobacillus Reuteri alters the level of inflammation in different compartments of the mother and the infant.

Conditions

• Pregnancy

Interventions

DRUG

Probiotic lozenges

The women participating in the study will take two probiotic lozenges per day (morning and evening) after meals.Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.

DRUG

Placebo lozenges

The women participating in the study will take two placebo lozenges per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.

DRUG

Probiotic capsules

The women participating in the study will take two probiotic capsules per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.

DRUG

Placebo capsules

The women participating in the study will take two placebo capsules per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.

DRUG

Probiotic chewing gum

The women participating in the study will take two probiotic chewing gums per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.

Sponsors & Collaborators

• BioGaia AB

  collaborator INDUSTRY

• Sahlgrenska University Hospital

  lead OTHER

Principal Investigators

• Bo Jacobsson, Professor · Göteborg University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2018-01-31

Completion

2018-01-31

Countries

• Sweden

Study Locations