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Completed

NCT Number: NCT02693028

Lactobacillus Reuteri Feasibility Study on Probiotic Treatment and Perinatal Microbiome

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, Sweden

About this study

The purpose of this project is to better understand the following issues:

  • 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?
  • Does colonization of the pregnant mother and fetus/Child occur? How and when?
  • Can orally given probiotic bacteria be found in the newborn 2-6 weeks after birth, and if so where?
  • How is bacteria transported from the mother's intestinal lumen to the Child/fetus gut?
  • 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?
  • What impact has these bacteria in the bowel on a normal intestinal flora establishment?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic lozenges

Drug

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

Placebo lozenges

Drug

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

Probiotic capsules

Drug

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

placebo capsules

Drug

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

Probiotic chewing gum

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • BioGaia AB

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2016
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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