Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02911077
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase
Start date September 27, 2016
Completion date August 29, 2017

See also
  Status Clinical Trial Phase
Completed NCT04473482 - Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial N/A
Completed NCT03340051 - Remote Alcohol Monitoring and Episodic Thinking N/A
Withdrawn NCT04659278 - Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use N/A
Completed NCT02829970 - Helping College Students With ADHD Lead Healthier Lifestyles N/A
Completed NCT02388243 - The Computer-based Drug and Alcohol Training Assessment in Kenya N/A
Completed NCT00248612 - Psychosocial and Medication Treatment for Anxiety in Alcoholism Phase 2/Phase 3
Recruiting NCT03535129 - A Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder N/A
Completed NCT00142844 - Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1 Phase 2
Completed NCT00000257 - Effects of Alcohol History on Effects of Nitrous Oxide - 9 N/A
Completed NCT00000278 - Disulfiram for Cocaine-Alcohol Abuse - 3 Phase 2
Recruiting NCT06074341 - TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study N/A
Not yet recruiting NCT05910580 - Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years N/A
Completed NCT02655354 - A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity N/A
Completed NCT01344122 - Medication-Assisted Treatment Implementation in Community Correctional Environments (MATICCE) N/A
Completed NCT01227980 - Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^ Phase 2
Completed NCT00400010 - Alcohol Expert System Intervention for Problematic Alcohol Use N/A
Completed NCT00391742 - Stepped Interventions for Problem Drinkers N/A
Completed NCT04725552 - Identifying and Managing Alcohol-related Health Problems in General Practice N/A
Completed NCT02968186 - Implementing Screening and Brief Interventions for Excessive Drinkers in Primary Health Care N/A
Completed NCT01847183 - Evaluation of an School-based Alcohol Prevention Program for Middle School Students Phase 2