Actively Recruiting
Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies
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 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.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Region Skåne
Lund, Sweden, 221 85
Actively Recruiting
Research Team
S
Stefan R Hansson, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here