Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRegion Skane

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

150 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Region Skane

Lead sponsor

ImmuneBiotech Medical Sweden AB

Collaborator