Overview

Lactobacillus Reuteri Feasibility Study on Probiotic Treatment and Perinatal Microbiome

Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Sahlgrenska University Hospital, Sweden
Collaborator:
BioGaia AB
Criteria
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.