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NCT06362356 · ClinicalTrials.gov registry record
Microbial Metabolites and Outcomes of Pregnancy Study
A clinical trial of Hypertensive Disorder of Pregnancy, sponsored by The Cleveland Clinic.
- Active
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT06362356 is a study of Hypertensive Disorder of Pregnancy that is active but no longer recruiting, run by The Cleveland Clinic. The registered enrollment target is 200 participants, below the 2,675-participant average among 8 other Hypertensive Disorder of Pregnancy trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06362356, a study of Hypertensive Disorder of Pregnancy, is active but no longer recruiting, sponsored by The Cleveland Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
Emerging data connect diet, the gut microbiota and its metabolites in cardiometabolic disease. Hypertensive disorders of pregnancy (HDP) are common and are a leading cause of maternal and neonatal morbidity. HDP likely share similar pathophysiology as cardiometabolic disease in non-pregnant people with a yet unrevealed role of diet and the gut microbiota, including systemic inflammation and endothelial dysfunction. Despite high biological plausibility that nutrition, the gut microbiota and its metabolites may play a role in health and disease in pregnancy, there is a paucity of data regarding these associations, thus limiting advancement of the field. Similar to the proposed pathogenesis for diet, gut microbiota and the microbial metabolite trimethylamine-N-oxide (TMAO) in cardiovascular disease, we hypothesize that the interplay between maternal diet, the gut microbiota and its associated microbial metabolites play a mechanistic role in HDP. We propose to test this hypothesis in a racially-diverse US cohort to determine association with adverse pregnancy outcomes, specifically future development of HDP. We propose to prospectively collect plasma and urine TMAO throughout pregnancy from a cohort of 200 pregnant participants. Through 1) characterizing plasma and urine TMAO levels across each trimester of pregnancy, and 2) assessment of this microbial metabolite as a predictor of development of HDP, we have the potential to identify a biomarker that would allow us to identify people at risk of HDP early in pregnancy and provide new opportunities for therapeutic interventions to improve maternal and neonatal outcomes.
Conditions Studied
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-03-05 |
| Est. Completion | 2026-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06362356
The ClinicalTrials.gov registry entry for NCT06362356 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,675-participant average among 8 other Hypertensive Disorder of Pregnancy trials with a reported enrollment target (93% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypertensive Disorder of Pregnancy appearing as the primary indexed condition, and to 0 interventions.
NCT06362356 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT06362356 about?
NCT06362356 is a clinical study titled "Microbial Metabolites and Outcomes of Pregnancy Study". Emerging data connect diet, the gut microbiota and its metabolites in cardiometabolic disease. Hypertensive disorders of pregnancy (HDP) are common and are a leading cause of maternal and neonatal morbidity. HDP likely share similar pathophysiology as cardiometabolic disease in non-pregnant people w...
What is the current status of trial NCT06362356?
This trial is currently active not recruiting. The enrollment target is 200 participants. The study started on 2024-03-05. Estimated completion is 2026-12-31.
What conditions does trial NCT06362356 study?
This clinical trial studies the following conditions: Hypertensive Disorder of Pregnancy.
Who is sponsoring clinical trial NCT06362356?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06362356 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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