NCT06700044Recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 10 Oct 2024
- Start date
- 10 Dec 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Region Skane
- NCT number
- NCT06700044
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 10 Dec 2024 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of other probiotic supplements in the last 2 weeks before baseline, or during the course of the study
- Current treatment with metformin, progesterone, or regular medical treatment which may impact study aim (e.g. laxatives)
Other illness
- Diabetes mellitus (type I and type II)
- Inflammatory bowel disease
- Celiac disease
- Other serious conditions that might affect gut flora or capability of the subject to participate
Other
- Enrollment in another clinical study
- Use of antibiotics in the last 6 weeks
- Immunosuppression
- Bad obstetric history
- Language difficulties or difficulties understanding informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Skane Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.