NCT06700044 Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies
| NCT ID | NCT06700044 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Preeclampsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-12-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06700044 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06700044 currently recruiting?
Yes, NCT06700044 is actively recruiting participants. Contact the research team at stefan.hansson@med.lu.se for enrollment information.
Where is the NCT06700044 trial being conducted?
This trial is being conducted at Lund, Sweden.
Who is sponsoring the NCT06700044 clinical trial?
NCT06700044 is sponsored by Region Skane. The trial plans to enroll 150 participants.