Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02911077 |
| Other study ID # |
160162 |
| Secondary ID |
16-CC-0162 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 27, 2016 |
| Est. completion date |
August 29, 2017 |
Study information
| Verified date |
April 3, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
