Lactobacillus Reuteri Feasibility Study on Probiotic Treatment and Perinatal Microbiome

Sahlgrenska University Hospital

Status: Completed

Conditions: Pregnancy

Treatments: Drug: Placebo lozenges; Drug: Placebo capsules; Drug: Probiotic lozenges; Drug: Probiotic chewing gum; Drug: Probiotic capsules

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02693028

Dnr. 085-15

Details and patient eligibility

About

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.

Full 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?

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 5 patient groups, including a placebo group

probiotic lozenge

Active Comparator group

Description:

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.

Treatment:

Drug: Probiotic lozenges

Probiotic capsule

Active Comparator group

Description:

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.

Treatment:

Drug: Probiotic capsules

Probiotic chewing gum

Active Comparator group

Description:

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.

Treatment:

Drug: Probiotic chewing gum

Placebo lozenge

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo lozenges

Placebo capsule

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo capsules