About this trial
Preeclampsia (PE) is a complication during pregnancy characterized by hypertension, organ damage, and inflammation, without an effective treatment. The underlying mechanisms causing the disease also remain partly unknown. In this double-blind placebo-controlled study, the effects of probiotic dietary supplement GutMagnific during pregnancy will be assessed in pregnancies with a high risk of PE as well as low risk. The hypothesis is that probiotic dietary supplement GutMagnific can prevent or reduce the inflammatory response and clinical manifestations associated with PE through counteracting imbalances in the oral and gut microbiome composition.
Eligibility criteria
Qualifiers
Pregnant women ≥ 18 years old
Auto-immune diseases such as SLE or anti-phospholipid syndrome
Previous preeclampsia or eclampsia
Previous hypertension of pregnancy with preterm birth before gestational week 34, growth restriction, intrauterine fetal death or ablatio
Disqualifiers
Enrollment in another clinical study
Use of other probiotic supplements in the last 2 weeks before baseline, or during the course of the study
Use of antibiotics in the last 6 weeks
Current treatment with metformin, progesterone, or regular medical treatment which may impact study aim (e.g. laxatives)
Trial design
Treatments tested in this trial
- GutMagnific
- Placebo
Treatment groups
Sponsors and collaborators
Region Skane
Lead sponsor
ImmuneBiotech Medical Sweden AB
Collaborator