CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Sodium Butyrate 5 mmol +1 moredrug
Likely dose
Sodium Butyrate 5 mmol 60 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04415333
NCT04415333Phase 1Completed
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Effect of Gut Butyrate Delivery on Blood Pressure in African Americans With Hypertension

University of North Carolina, Chapel Hill·interventional·Posted Jun 4, 2020·Updated Oct 18, 2023

In Brief

A Phase 1 clinical trial evaluating Sodium Butyrate 5 mmol and Sodium Butyrate 80 mmol for Hypertension. Completed, enrolled 20 participants across 1 site.

Detailed Summary

African Americans have the greatest burden of hypertension. Recently, the short-chain fatty acid, butyrate, has been reported to have some effect on blood pressure. Butyrate is not normally ingested since it is made by bacteria in the gut as a byproduct of fiber fermentation. In this proof of concept study, the investigators will investigate the effect of butyrate absorbed in the gut (via the participant self-administering an enema with butyrate) has on blood pressure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States
CollaboratorsNorth Carolina Translational and Clinical Sciences Institute, North Carolina Agriculture & Technical State University

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJun 4, 2020
Enrollment StartJul 8, 2021
Primary CompletionNov 1, 2021
Study CompletionNov 2, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.1 years ago

Interventions

Sodium Butyrate 5 mmoldrug

Enema-based delivery of 5 mmol butyrate in 0.9% saline, (60 mL total)

Sodium Butyrate 80 mmoldrug

Enema-based delivery of 80 mmol butyrate in 0.9% saline, (60 mL total)