Probiotic supplementation for pregnant women at high risk of preeclampsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Region Skåne
  Lund, Sweden Recruiting

Study contacts

• Study coordinator: Stefan R Hansson, Professor
• Email: stefan.hansson@med.lu.se
• Phone: +46 70 6024476

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Role of Progesterone Membrane Receptors in Preeclampsia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.