Lactobacillus Reuteri Feasibility Study on Probiotic Treatment and Perinatal Microbiome

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Drug: Probiotic capsules; Drug: Probiotic lozenges; Drug: Probiotic chewing gum; Drug: Placebo lozenges; Drug: Placebo capsules

• Registration Number: NCT02693028
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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?

Study Timeline

• Study First Submitted: 2015-10-12
• Study Start: 2015-11
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-26
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Single or multiple gestation
• Maternal age > or = 18 y

Exclusion Criteria

• Known structural or chromosomal fetal malformation or abnormality
• Occlusive placenta previa, placenta previa in the anterior wall of the uterus, suspicion of accreta/increta/percreta infiltration
• Unable to understand information about the study due to language or severe mental disease
• Known Hepatitis B, C, HIV
• Known immunosuppressive illness if they are under treatment
• Treatment with cytokine, methotrexate or immunosuppresses cytotoxics in the last 6 months before the study.
• Gastro-intestinal surgery including gastric bypass or huge intestinal resection.
• Anaphylactic shock
• Uterus malformation that occludes cervical Canal or uterus segment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic capsule	Probiotic capsules	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.
probiotic lozenge	Probiotic lozenges	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.
Probiotic chewing gum	Probiotic chewing gum	The probiotic chewing gum should be chewed on for about 10 minutes. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
Placebo lozenge	Placebo lozenges	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.
Placebo capsule	Placebo capsules	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.

Primary Outcome Measures

Name	Time	Method
Presence of Lactobacillus reuteri in different compartments in the mother and the Child.	Mother: From weeks 28-36 of pregnancy until 6 weeks post partum. Child: from birth till 4 years old.	Both cultivation techniques for the specific bacteria and metagenomic techniques will be used to be able to study both cultivable and non-cultivable bacteria.

Secondary Outcome Measures

Name	Time	Method
Levels of IL-6, IL-10, IL-1beta, MCP-1, IL-17, TNF-alfa after probiotic treatment and after placebo in different maternal and neonatal compartments.	Mother: From weeks 28-36 of pregnancy until 6 weeks post partum. Child: from birth till 4 years old.	To evaluate whether there are differences in the levels of cytokines and chemokines in different compartments between women treated with probiotic and the placebo group
Levels of Toll-like receptor stimulated with Lactobacillus plantarum, Pseudomonas aeruginosa and LPS after probiotic treatment and after placebo in different maternal and neonatal compartments.	Mother: From weeks 28-36 of pregnancy until 6 weeks post partum. Child: from birth till 4 years old.	To evaluate whether there are differences in Toll-like receptor stimulation with Lactobacillus plantarum, Pseudomonas aeruginosa and LPS in different compartments between women treated with probiotic and the placebo group

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden