Actively Recruiting
Assessing Effects of Probiotic Supplement GutMagnific in Women With High-Risk Pregnancies to Study Preeclampsia
Led by Region Skane · Updated on 2024-12-27
150
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
R
Region Skane
Lead Sponsor
I
ImmuneBiotech Medical Sweden AB
Collaborating Sponsor
AI-Summary
What this Trial Is About
Preeclampsia (PE) is a serious pregnancy complication marked by high blood pressure, organ damage, and inflammation, with no effective treatment currently available. This research investigates the effects of the probiotic dietary supplement GutMagnific on pregnant women with both high and low risk of developing PE. The study hypothesizes that GutMagnific may help prevent or lessen inflammation and clinical symptoms of PE by improving imbalances in the oral and gut microbiome. Participants will be randomly assigned to take either one daily dose of GutMagnific or a placebo from around gestational week 12 until week 37 or until birth. GutMagnific is a probiotic supplement originally developed for irritable bowel syndrome and shown to support gut health by reducing inflammation and repairing the gut barrier. The study will include women with varying risk levels for PE, based on specific medical and demographic factors. Throughout the study, samples will be collected around gestational weeks 12, 28, 37, and 6-8 weeks postpartum to monitor changes in oral and gut microbiota. If a participant develops PE, additional samples will be taken at diagnosis. Researchers will assess microbiome composition and track clinical outcomes related to PE. The study also includes monitoring for safety and adherence to the supplement over the pregnancy and postpartum periods.
CONDITIONS
Official Title
Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women aged 18 years or older
- High risk of preeclampsia with at least 1 high-risk factor or 3 or more moderate risk factors according to Swedish guidelines
- Low risk of preeclampsia with no high-risk factors and fewer than 3 moderate risk factors
- Ability to provide written informed consent
You will not qualify if you...
- Participation in another clinical study
- Use of probiotic supplements within 2 weeks before baseline or during the study
- Use of antibiotics within the last 6 weeks
- Current treatment with metformin, progesterone, or other medications affecting the study
- Immunosuppression
- Diabetes mellitus type 1 or 2
- Inflammatory bowel disease
- Celiac disease
- History of bad obstetric outcomes
- Other serious medical conditions affecting gut flora or participation
- Language difficulties or inability to understand informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Region Skåne
Lund, Sweden, 221 85
Actively Recruiting
Research Team
S
Stefan R Hansson, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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