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

NCT02911077 | Completed

• 2 other identifiers: 16016216-CC-0162
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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 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

Keywords

Bacteria; Natural History

Outcome Measures

Primary Outcomes (1)

• Identification of bacteria in the gut and oral microbiomes over time

  Characterization of the gut and oral micro biome

  all timepoints

Study Arms (1)

AUD population

The participants/group were treatment-seeking AUD individuals admitted to the NIH CC 1SE Addictions Unit.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

inpatient treatment seeking alcohol dependent participants

You may qualify if:

• At least 18 years of age
• Willing to provide consent
• Consented on screening and research protocol 14-AA-0181
• Admitted to the NIH CC for inpatient detoxification treatment

You may not qualify if:

• Currently using or have used any of the following drugs within the last month by self-report:
• Antibiotics
• Corticosteroids: inhaled, oral, intravenous or intramuscular
• Immunosuppressive or cytotoxic agents
• Large doses of probiotics such as supplemental probiotics (ordinary dietary components such as beverages/milk or yogurt DO NOT APPLY)
• Any bowel resection at any time.
• History of active uncontrolled gastrointestinal disorders or diseases including inflammatory bowel disease, ulcerative colitis, Crohn s disease, and/or infectious gastroenteritis, colitis, or gastritis (per patient s report of whether or not they have been diagnosed by a physician).
• Enrolled in any investigational study that might affect the microbiome.
• BMI greater than or equal to 30 kg/m2

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Alcoholic Intoxication; Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Katherine A Maki, C.R.N.P.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 22, 2016
• Study Start: September 27, 2016
• Primary Completion: August 29, 2017
• Study Completion: August 29, 2017
• Last Updated: May 1, 2026

Record last verified: 2026-01-16

Locations

US (1)