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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

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

Brief 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 fir

Detailed Summary: The microbiome exists in a complex symbiotic relationship with its human host, the characterization of which is imperative for understanding a myriad of diseases. Until recently, much of gut microbiome research has focused on gastrointestinal disorders. Recent research, however, has implicated the gut microbiome in psychological disorders as well through a proposed gut-brain axis. Of particular interest is characterization of the microbiome of individuals with severe alcohol use disorders, as alcohol has been known to profoundly alter the gut microbiome. For many years, scientists have theorized a connection between the proinflammatory mediators produced by ethanol consumption, liver disease and the gut microbiome. This study represents the first instance in which the naturalistic time course of changes in the gut microbiome will be followed in alcoholics in whom detailed history of alcohol consumption and diet have been obtained. We hypothesize that the gut microbiome will renormalize spontaneously and without specific intervention over a time frame of one or two weeks. Alcoholic patients also suffer from serious oral hygiene problems associated with alterations in oral microbial flora. We hypothesize that abnormalities in the oral microbiome will be detectable on admission, and that these will also rapidly renormalize with abstinence and resumption of ordinary diet and oral hygiene. If not, the findings in this study could point to the need for other interventions, such as administration of probiotics. Twenty evaluable participants admitted to the Clinical Center for alcohol detoxification will be enrolled. All patients will be admitted under the Unit and Clinic Evaluation, Screening, Assessment, and Management protocol (14-AA-0181), which includes adults 18 years of age or older seeking treatment for severe alcohol use disorders. Oral (tongue brushings) and gut (stool) specimens will be collected daily until for the first week. And then once a week for 28 days. D
Sponsor: National Institutes of Health Clinical Center (CC)

Current Primary Outcome: Identification of bacteria in the gut and oral microbiomes over time [ Time Frame: Study Completion ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: September 21, 2016
Date Started: August 4, 2016
Date Completion: May 1, 2018
Last Updated: April 21, 2017
Last Verified: April 7, 2017