RecruitingNot ApplicableNCT06700044

Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies

Assessing the Effects of Probiotic Supplementation in Women With High-Risk Pregnancies: A Randomized Controlled Trial


Sponsor

Region Skane

Enrollment

150 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking probiotic supplements (beneficial bacteria) during pregnancy can help reduce the risk of preeclampsia — a dangerous condition involving high blood pressure that can develop during pregnancy. **You may be eligible if...** - You are pregnant and at least 18 years old - You are at high or moderate risk of developing preeclampsia (due to factors like a previous history of preeclampsia, diabetes, chronic high blood pressure, or being pregnant through egg donation IVF) - You are able to give written consent **You may NOT be eligible if...** - You are already enrolled in another clinical study - You have taken probiotics in the last 2 weeks or antibiotics in the last 6 weeks - You have an immune system condition, inflammatory bowel disease, celiac disease, or diabetes - You are currently taking metformin, progesterone, or other medications that could affect the study results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTGutMagnific

Participants will take one stick/10\^9 CFU of probiotic dietary supplement GutMagnific per day from gestational week 12 until gestational week 37

DIETARY_SUPPLEMENTPlacebo

Participants will take one stick/placebo per day from gestational week 12 until partus.


Locations(1)

Region Skåne

Lund, Sweden

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NCT06700044


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