Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies

NCT06700044 | Recruiting

• 1 other identifier: Dnr 2024-03036-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Preeclampsia; Gut Dysbiosis

Keywords

preeclampsia; probiotics; microbiome; lactobacillus; pregnancy; GutMagnific

Outcome Measures

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.

  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 (8)

• Changes in gastrointestinal symptoms

  At the baseline and every two weeks until 6-8 weeks postpartum.

• Changes in blood pressure

  At the baseline and continuously every 2-3 weeks from gestational week 24 throughout the pregnancy, and 6-8 weeks postpartum.

• Differences in obstetric outcome

  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.

• Changes in oral glucose tolerance test results

  Gestational week 28

• Changes in circulatory Short-chain fatty acids (SCFAs) levels

  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.

Study Arms (4)

High-risk probiotic

ACTIVE COMPARATOR

50 pregnant women with high risk of developing PE will take one stick/10\^9 CFU of probiotic dietary supplement GutMagnific per day from gestational week 12 until partus.

Dietary Supplement: GutMagnific

High-risk placebo

PLACEBO COMPARATOR

50 pregnant women with high risk of developing PE will take one stick/placebo per day from gestational week 12 until partus.

Dietary Supplement: Placebo

Low-risk probiotic

ACTIVE COMPARATOR

25 pregnant women with low risk of developing PE will take one stick/10\^9 CFU of probiotic dietary supplement GutMagnific per day from gestational week 12 until partus.

Dietary Supplement: GutMagnific

Low-risk placebo

PLACEBO COMPARATOR

25 pregnant women with low risk of developing PE will take one stick/placebo per day from gestational week 12 until partus.

Dietary Supplement: Placebo

Interventions

GutMagnific DIETARY_SUPPLEMENT

Participants will take one stick/10\^9 CFU of probiotic dietary supplement GutMagnific per day from gestational week 12 until gestational week 37

High-risk probiotic; Low-risk probiotic

Placebo DIETARY_SUPPLEMENT

Participants will take one stick/placebo per day from gestational week 12 until partus.

High-risk placebo; Low-risk placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead
• ImmuneBiotech Medical Sweden AB: collaborator

Study Sites (1)

Region Skåne

Lund, 221 85, Sweden

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Stefan R Hansson, Professor

CONTACT

+46 70 6024476; stefan.hansson@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: November 21, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)