Lactobacillus Reuteri Feasibility Study on Probiotic Treatment and Perinatal Microbiome

December 11, 2018 updated by: Bo Jacobsson, Sahlgrenska University Hospital, Sweden

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: probiotic lozenge
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: 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.
Other Names:
  • Lactobacillus reuteri lozenges
Active Comparator: Probiotic capsule
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: 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.
Other Names:
  • Lactobacillus reuteri capsules
Active Comparator: 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.
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.
Other Names:
  • Lactobacillus reuteri chewing gum
Placebo Comparator: Placebo lozenge
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: 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.
Other Names:
  • "non active" treatment lozenges
Placebo Comparator: Placebo capsule
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: 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.
Other Names:
  • "non active" treatment capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Lactobacillus reuteri in different compartments in the mother and the Child.
Time Frame: 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.
Mother: From weeks 28-36 of pregnancy until 6 weeks post partum. Child: from birth till 4 years old.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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
Mother: From weeks 28-36 of pregnancy until 6 weeks post partum. Child: from birth till 4 years old.
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.
Time Frame: 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
Mother: From weeks 28-36 of pregnancy until 6 weeks post partum. Child: from birth till 4 years old.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

BioGaia AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

December 12, 2018

Last Update Submitted That Met QC Criteria

December 11, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Dnr. 085-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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