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Completed No phase listed Observational

Exploring Gut-Brain and Brain-Gut Interactions in Alcohol Use Disorder Via Microbiota Investigations: A Pilot Study

ClinicalTrials.gov ID: NCT03152760

Public ClinicalTrials.gov record NCT03152760. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 5:40 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Background: Alcohol use disorder (AUD) affects about 10 percent of people in the U.S. Studies show a relationship between the bacteria (microbiota) in the gut and the brain. Researchers think this may influence AUD. They want to learn more about changes in gut bacteria that may occur in people with AUD. Objectives: To study gut microbiota differences in current drinking versus abstinent people with AUD. Also to test if gut microbiota are related to alcohol cue-induced craving. Eligibility: People ages 21-70 who have AUD (both abstinent and current heavy drinkers) or are healthy, moderate drinkers Design: Participants will be screened in Protocol 14-AA-0181. Participants will have a first visit. They will have 4 more visits within about 10 days. Visits include: Fecal sample collection Physical exam Blood tests Assessment of diet and alcohol use X-rays to test body composition, They will sit under a ventilation hood to measure metabolism. They must fast 12 hours before this test. They will drink a solution. Their urine is collected over 5 hours. Ultrasound of the liver area. They must fast overnight before this test. At 2 visits, they will be in a bar-like setting. They will be exposed to stimuli associated with eating and drinking. They will rate their urge to drink alcohol and their food cravings. Participants will collect their stool throughout the study. They will also record information about their diet and daily activities like sleep and exercise. At the end of the study, participants will discuss their drinking. They will receive counseling if needed.

Study identification

NCT ID
NCT03152760
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
35 participants

Conditions and interventions

Conditions

Interventions

Not listed

Eligibility (public fields only)

Age range
21 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 27, 2017
Primary completion
Mar 3, 2020
Completion
Nov 23, 2020
Last update posted
Aug 11, 2026

2017 – 2020

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institutes of Health Clinical Center Bethesda Maryland 20892

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03152760, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 11, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03152760 live on ClinicalTrials.gov.

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