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Longitudinal Changes in the Oral and Gut Microbiome of Individuals With Alcohol Dependence

NCT02911077 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 23

Last updated 2026-05-01

No results posted yet for this study

Summary

Background:

Many bacteria live in the gut. The gut is the tube that moves food from the mouth through the stomach to the intestines. Heavy alcohol use disturbs these bacteria. There is evidence that the bacteria in the gut may affect anxiety and depression. Researchers want to learn more about these bacteria in order to better treat diseases such as alcohol dependence.

Objective:

To identify the different bacteria that live in the mouth and gut. Also, to learn if these bacteria change as a person goes through alcohol detoxification.

Eligibility:

People ages 18 and older who:

* Enrolled in screening protocol 14-AA-0181
* Are going through detoxification treatment at the Clinical Center

Design:

Participants will have physical exams.

Participants will answer questions about:

* Anxiety and depression
* Alcohol use
* Sleep
* Abdominal and oral health
* Diet

Participants will keep a regular record of their diet.

Participants will have breath alcohol analysis 4 times per day.

Participants will provide stool and oral specimens at most once a day for the first week. Then, they will provide them once a week while they are at the Clinical Center.

* For the oral specimen: A small brush rubs the tongue. They may not eat, drink, or perform oral care within 2 hours of collection.
* For the stool specimen: They will receive a container that fits in the toilet. They will let the nurse know right away when the sample is ready.

Participants will have a dental visit. This consists of an oral exam and oral health assessment. The dentist may recommend a cleaning or dental X-rays.

Conditions

  • Alcoholic Intoxication
  • Alcohol-Related Disorders

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Katherine A Maki, C.R.N.P. · National Institutes of Health Clinical Center (CC)

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-27
Primary Completion
2017-08-29
Completion
2017-08-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02911077 on ClinicalTrials.gov