NCT06700044

Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies

Assessing the Effects of Probiotic Supplementation in Women With High-Risk Pregnancies: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PE is a leading cause of maternal and fetal morbidity and mortality worldwide, affecting 3-7% of pregnant women. PE is characterized by hypertension and organ damage manifesting after 20 gestational weeks, and is associated with an increased systemic inflammatory response in the mother. The clinical manifestations may vary greatly and are often more severe in early-onset PE (onset \<34 gestational weeks) than late-onset PE (onset ≥34 gestational weeks). Severe features include blood-pressure ≥160/110 mmHg, severe organ dysfunction, stroke, and eclampsia. Placental failure is central in the pathophysiology of PE, although the underlying mechanisms causing the disease remain partly unknown. Current research, including a previous study conducted by the investigators, suggests that disturbances in the gut microbiome might be involved in the pathogenesis of PE, leading to a dysfunctional immune response and damaged gut barrier functions. The investigators' previous study also indicated that PE is associated with gastrointestinal symptoms. GutMagnific is an evidence-based probiotic dietary supplement, shown to be effective in correcting disturbances in the gut microbiome, reduce inflammation and repair a damaged gut barrier. It was originally developed for treatment of irritable bowel syndrome (IBS). There is an overlap in immunological responses involved in PE and IBS, and women with IBS have a higher risk of developing PE. Therefore, the investigators expect that the product might also have positive effects in pregnant women with a high risk of PE.

Conditions

• Preeclampsia
• Gut Dysbiosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	GutMagnific	Participants will take one stick/10\^9 CFU of probiotic dietary supplement GutMagnific per day from gestational week 12 until gestational week 37
DIETARY_SUPPLEMENT	Placebo	Participants will take one stick/placebo per day from gestational week 12 until partus.

Timeline

• Start date: 2024-12-10
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-11-21
• Last updated: 2024-12-27

Locations

1 site across 1 country: Sweden