Probiotic supplementation for pregnant women at high risk of preeclampsia
Assessing the Effects of Probiotic Supplementation in Women With High-Risk Pregnancies: A Randomized Controlled Trial
This study is testing whether a probiotic supplement can help pregnant women at high risk for preeclampsia feel better and lower their chances of developing the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Region Skane Academic / other |
| Locations | 1 site (Lund) |
| Trial ID | NCT06700044 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of the probiotic dietary supplement GutMagnific on pregnant women who are at high risk for developing preeclampsia (PE). The study is designed as a double-blind, placebo-controlled trial, comparing the probiotic's impact on inflammatory responses and clinical manifestations associated with PE. Participants will include both high-risk and low-risk pregnant women, with the aim of understanding how GutMagnific can potentially correct gut microbiome imbalances and reduce the risk of PE. The trial will assess the safety and efficacy of the probiotic in preventing or alleviating symptoms of PE during pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older who are classified as high risk for preeclampsia or low risk based on specific medical criteria.
Not a fit: Patients who are not pregnant or those without any risk factors for preeclampsia may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel preventive approach to reduce the incidence and severity of preeclampsia in high-risk pregnant women.
How similar studies have performed: Previous studies have suggested a link between gut microbiome disturbances and preeclampsia, indicating that this approach may hold promise, although the specific use of GutMagnific in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lund
- Region Skåne — Lund, Sweden (Recruiting)
Study contacts
- Study coordinator: Stefan R Hansson, Professor
- Email: stefan.hansson@med.lu.se
- Phone: +46 70 6024476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.