Alcoholic IntoxicationNCT02911077
Longitudinal Changes in the Oral and Gut Microbiome of Individuals With Alcohol Dependence
An observational study of Alcoholic Intoxication and Alcohol-Related Disorders, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Alcoholic Intoxication, Alcohol-Related Disorders
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2016to 29 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: inpatient treatment seeking alcohol dependent participants
Who may be able to join
- 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
Who cannot join
- 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)
- Major surgery of the GI tract with the exclusion of cholecystectomy and appendectomy in the past 5 years.
Show all 11Show fewer
- 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
- Some of these exclusionary criteria have been adapted from the Human Microbiome Project [40]. All exclusion measures will be collected from self-report.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
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 for the first week and then once a week for 28 days. Demographic characteristics, detailed drinking and dietary histories, measures of addiction severity, comorbid mental disorders, and metabolic indicators of other disease will be collected for correlation with microbiological results. Dietary records will include use of probiotics. Exclusion criteria include use of antibiotics, corticosteroids or immunosuppressive agents within the past month. Informed consent will be obtained after consent for the screening and treatment protocol (14-AA-0181) and in accordance with policies protecting participants with impaired decision-making. Microbial identification will include 16S rRNA analysis and a validated Next Generation Sequencing analysis pipelines. Statistical comparisons between each patient's oral and gut microbiome samples will be evaluated and all results from this population will also be compared to published microbiomes in both healthy volunteers as well as existing data from alcohol dependent individuals. Participants will be compensated for research-related discomfort and inconveniences in accordance with NIH guidelines.
- Conditions
- Alcoholic Intoxication, Alcohol-Related Disorders
- Keywords
- Bacteria, Natural History
- Medical subject headings
- Alcoholic Intoxication, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AUD population | The participants/group were treatment-seeking AUD individuals admitted to the NIH CC 1SE Addictions Unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of bacteria in the gut and oral microbiomes over time
Characterization of the gut and oral micro biome
Measured: all timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start27 Sep 2016
- Primary completion29 Aug 2017
- Study completion29 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic IntoxicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Katherine A Maki, C.R.N.P., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911077
- Sponsor's protocol ID
- 160162
- Other IDs
- 16-CC-0162
- Status last verified
- 15 Sep 2026
- First submitted
- 21 Sep 2016
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Changes in the Oral and Gut Microbiome of Individuals With Alcohol Dependence
- ClinicalTrials.gov ID
- NCT02911077
- Acronym / sponsor ID
- 160162
- Conditions
- Alcoholic Intoxication, Alcohol-Related Disorders
- Keywords
- Bacteria, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 29 Aug 2017 (actual)
- Study completion
- 29 Aug 2017 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 for the first week and then once a week for 28 days. Demographic characteristics, detailed drinking and dietary histories, measures of addiction severity, comorbid mental disorders, and metabolic indicators of other disease will be collected for correlation with microbiological results. Dietary records will include use of probiotics. Exclusion criteria include use of antibiotics, corticosteroids or immunosuppressive agents within the past month. Informed consent will be obtained after consent for the screening and treatment protocol (14-AA-0181) and in accordance with policies protecting participants with impaired decision-making. Microbial identification will include 16S rRNA analysis and a validated Next Generation Sequencing analysis pipelines. Statistical comparisons between each patient's oral and gut microbiome samples will be evaluated and all results from this population will also be compared to published microbiomes in both healthy volunteers as well as existing data from alcohol dependent individuals. Participants will be compensated for research-related discomfort and inconveniences in accordance with NIH guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUD population | – | –The participants/group were treatment-seeking AUD individuals admitted to the NIH CC 1SE Addictions Unit. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- inpatient treatment seeking alcohol dependent participants
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Currently using or have used any of the following drugs within the last month by self-report:
- Large doses of probiotics such as supplemental probiotics (ordinary dietary components such as beverages/milk or yogurt DO NOT APPLY)
- Major surgery of the GI tract with the exclusion of cholecystectomy and appendectomy in the past 5 years.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of bacteria in the gut and oral microbiomes over time
Time frame: all timepoints
Characterization of the gut and oral micro biome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine A Maki, C.R.N.P. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Intoxication and Alcohol-Related Disorders, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of bacteria in the gut and oral microbiomes over time (time frame: all timepoints). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.