Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies
Recruiting · NCT06700044 · Interventional (participants receive a specific treatment) · Lead sponsor: Region Skane
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Pregnant women ≥ 18 years old
- High risk of PE (≥ 1 high-risk factor, or ≥3 moderate risk factors according to the Swedish Society of Obstetrics and Gynecology (SFOG) 2019 guidelines); or low risk of PE (no high-risk factors, or \<3 moderate risk factors):
- High risk factors are:
- 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
- Type 1 or 2 diabetes
- Duplex (or triplex) pregnancy
- Kidney disease
- Chronic hypertension
- IVF with egg donation
- Moderate risk factors are:
- Nulliparity
- Heredity for preeclampsia (at least one of mother, maternal grandmother, or sister)
- BMI\>30
- Age\>40
- Pregnancy interval \>10 years
- Systolic blood pressure \>130 mmHg or diastolic blood pressure \> 80 mmHg at admission in antenatal maternity care
- African descent
- Verified obstructive sleep apnea
- Ability to give written informed consent
Exclusion criteria
- 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)
- Immunosuppression
- Diabetes mellitus (type I and type II)
- Inflammatory bowel disease
- Celiac disease
- Bad obstetric history
- Other serious conditions that might affect gut flora or capability of the subject to participate
- Language difficulties or difficulties understanding informed consent
Where it is running
1 location listed.
- Region Skåne - Lund, Sweden