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Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies

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…

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ClinicalTrials.gov IDNCT06700044

PhaseNA

Enrollment150

SponsorRegion Skane

Age18 Years and older

SexFEMALE

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Conditions studied

Preeclampsia, Gut Dysbiosis

About this study

Interventions

Dietary Supplement: GutMagnific — Participants will take one stick/10\^9 CFU of probiotic dietary supplement GutMagnific per day from gestational week 12 until gestational week 37
Dietary Supplement: Placebo — Participants will take one stick/placebo per day from gestational week 12 until partus.

Primary outcomes

Changes in oral and gut microbiota composition (Around gestational week 12 (baseline), 28, 37, and 6-8 weeks postpartum. In the event of a participant developing PE, samples will be taken at PE diagnosis as well.)

Eligibility information

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

Study locations

Region Skåne, Lund, 221 85 Sweden

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.