CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Seed DS-01 Daily Synbioticdietary
Likely dose
Not stated in 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/NCT05232682
NCT05232682Phase 2Completed
CompareCT.gov

Probiotics, Immune Function, and the Brain in Alcohol Consumers

Brown University·interventional·Posted Feb 10, 2022·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating Seed DS-01 Daily Synbiotic for Alcohol; Use, Problem. Completed, enrolled 32 participants across 1 site.

Detailed Summary

This pilot project is a brief, open-label clinical trial of probiotics as an intervention in heavy drinkers. Heavy drinkers who do not yet show significant signs of liver disease may stand to benefit from probiotics, but no clinical trials to date have addressed this population. This study will recruit heavy drinkers to complete an open-label within-subjects trial. The study will investigate effects of probiotics on specific biomarkers in healthy heavy drinkers who currently are not seeking to change their alcohol use (i.e., are non-treatment-seeking).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol; Use, Problem
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedFeb 10, 2022
Enrollment StartFeb 24, 2022
Primary CompletionAug 9, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.4 years ago

Interventions

Seed DS-01 Daily Synbioticdietary

Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)