NCT02693041

Pregnancy Complications - A Probiotic Interventional Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Investigators hypothesize that a) probiotics decrease the overall inflammatory state in the pregnant woman, especially in women with high risk pregnancies.

Detailed description

The main of the Project is to determine if dietary supplementation intake of probiotics are associated with a decreased inflammatory response in pregnant women, especially those with a history of previous preterm birth or preeclampsia, in a randomized clinical trial. Investigators also want to further investigate the relationship between intake of probiotics and the degree of inflammation in different compartments during pregnancy to see how the probiotic components affect the inflammatory state in the women.

Conditions

• Preeclampsia
• Preterm Birth

Interventions

Type	Name	Description
DRUG	probiotic	Low-risk women, women with prior preeclampsia and women with a prior preterm birth will be randomized to be treated with LGG during pregnancy. Effect on maternal and perinatal outcome as well as the effect of treatment on immunological and inflammatory biomarkers will be evaluated.
DRUG	placebo	Low-risk women, women with prior preeclampsia and women with a prior preterm birth will be randomized to be treated with placebo during pregnancy. Effect on maternal and perinatal outcome as well as the effect of treatment on immunological and inflammatory biomarkers will be evaluated.

Timeline

• Start date: 2012-06-01
• Primary completion: 2021-09-27
• Completion: 2021-09-27
• First posted: 2016-02-26
• Last updated: 2022-06-03

Locations

1 site across 1 country: Sweden