NCT02693028

Lactobacillus Reuteri Feasibility Study on Probiotic Treatment and Perinatal Microbiome

Lactobacillus Reuteri Feasibility Study on Probiotic Lozenges, Probiotic Chewing Gum and Probiotic Capsules and Perinatal Microbiome Seeding During Pregnancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this project is to better understand the following issues: 1. How does bacteria transmit from the mother to the fetus and placenta during pregnancy and to the infant during the first 2-6 weeks after birth? 2. Does colonization of the pregnant mother and fetus/Child occur? How and when? 3. Can orally given probiotic bacteria be found in the newborn 2-6 weeks after birth, and if so where? 4. How is bacteria transported from the mother's intestinal lumen to the Child/fetus gut? 5. What impact has these bacteria on the level of inflammation in maternal and fetal compartments, especially that normally seen in the intestine of all newborns? 6. What impact has these bacteria in the bowel on a normal intestinal flora establishment?

Conditions

• Pregnancy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2016-02-26
• Last updated: 2018-12-12

Locations

1 site across 1 country: Sweden