Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRegion Skane
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women ≥ 18 years old
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
GutMagnific
Dietary supplementParticipants will take one stick/10\^9 CFU of probiotic dietary supplement GutMagnific per day from gestational week 12 until gestational week 37
Placebo
Dietary supplementParticipants will take one stick/placebo per day from gestational week 12 until partus.
Treatment groups
150 Participants
are divided into 4 treatment groupsGroup A: High-risk probioticActive comparator 1 intervention
Group B: High-risk placeboPlacebo comparator 1 intervention
Group C: Low-risk probioticActive comparator 1 intervention
Group D: Low-risk placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in oral and gut microbiota composition
Fecal and salivary samples will be analyzed using next-generation sequencing techniques to monitor possible changes related to probiotic supplement, and possible associations with obstetric outcome (especially PE incidence) will be assessed. Samples taken prior to, during and after probiotic treatment in the same participant will be compared.
Time frame
Around gestational week 12 (baseline), 28, 37, and 6-8 weeks postpartum. In the event of a participant developing PE, samples will be taken at PE diagnosis as well.Secondary outcomes
1
Changes in gastrointestinal symptoms
A modified questionnaire for irritable bowel syndrome (IBS) symptoms will be filled in by participants grading different gastrointestinal symptoms from 1-10. Higher score indicates better condition.
Time frame
At the baseline and every two weeks until 6-8 weeks postpartum.2
Changes in blood pressure
Blood pressure measurements at standard midwife appointments in antenatal care.
Time frame
At the baseline and continuously every 2-3 weeks from gestational week 24 throughout the pregnancy, and 6-8 weeks postpartum.3
Differences in obstetric outcome
Incidence of adverse events during pregnancy, including PE, fetal growth restriction, gestational hypertension, gestational diabetes mellitus, and preterm birth.
Time frame
Data will be collected from the Swedish Pregnancy Register (Graviditetsregistret) and/or medical records through study completion, an average of 6 months for term pregnancies.4
Changes in oral glucose tolerance test results
Blood glucose levels before (fasting) and after standard oral glucose tolerance test will be assessed to study possible effects of probiotic supplementation.
Time frame
Gestational week 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Skane
Lead sponsor
ImmuneBiotech Medical Sweden AB
Collaborator
Source ClinicalTrials.gov