Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies

Sponsor
Region Skane
Study ID
NCT06700044
Status
Recruiting
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Conditions

  • Gut Dysbiosis
  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Nov 21, 2024
Start date
Dec 10, 2024
Status verified
Dec 2024
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: High-risk probiotic
    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.
  • Placebo Comparator: High-risk placebo
    50 pregnant women with high risk of developing PE will take one stick/placebo per day from gestational week 12 until partus.
  • Active Comparator: Low-risk probiotic
    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.
  • Placebo Comparator: Low-risk placebo
    25 pregnant women with low risk of developing PE will take one stick/placebo per day from gestational week 12 until partus.

Primary Outcome Measure

Changes in oral and gut microbiota composition [ 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. ]

Central Contacts

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