NCT02911077

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

Completed Last updated 9 March 2026

What this trial tests

trial in Alcoholic Intoxication in 23 participants. Completed in 29 August 2017.

Timeline

27 September 2016

Primary endpoint
29 August 2017

29 August 2017

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	23
Start date	27 September 2016
Primary completion	29 August 2017
Estimated completion	29 August 2017
Sites	1 location across United States

Conditions studied

• Alcoholic Intoxication — all drugs for Alcoholic Intoxication →
• Alcohol-Related Disorders — all drugs for Alcohol-Related Disorders →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 18 to 99, any sex, with Alcoholic Intoxication or Alcohol-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Longitudinal gut microbiome changes in alcohol use disorder are influenced by abstinence and drinking quantity.
   Ames NJ, Barb JJ, Schuebel K, Mudra S, et al · · 2020 · cited 56× · PMID 32615913 · DOI 10.1080/19490976.2020.1758010
2. The oral microbiome in alcohol use disorder: a longitudinal analysis during inpatient treatment.
   Barb JJ, Maki KA, Kazmi N, Meeks BK, et al · · 2022 · cited 25× · PMID 34880965 · DOI 10.1080/20002297.2021.2004790
3. Dietary Intakes of Patients with Alcohol Use Disorder During a 4-Week Protocol on an Inpatient Treatment Unit Found to Meet Dietary Reference Intakes for Macronutrients, but Have Variability in Energy Balance and Adequacy of Micronutrient Intake.
   Yang S, Ratteree K, Turner SA, Tuason RT, et al · · 2022 · cited 4× · PMID 35659642 · DOI 10.1016/j.jand.2022.05.022
4. The gut-brain axis in individuals with alcohol use disorder: An exploratory study of associations among clinical symptoms, brain morphometry, and the gut microbiome.
   Maki KA, Wallen GR, Bastiaanssen TFS, Hsu LY, et al · · 2024 · cited 1× · PMID 38982564 · DOI 10.1111/acer.15346
5. Longitudinal assessment of oral and gut microbiome overlap in patients with Alcohol Use Disorder undergoing inpatient treatment.
   Barb JJ, Hughes AN, Nanda S, Tuason RTS, et al · · 2025 · PMID 41346362 · DOI 10.3389/fcimb.2025.1681781