Protocol Details
Longitudinal Changes in the Oral and Gut Microbiome of Individuals with Alcohol Dependence
This study is NOT currently recruiting participants.
Summary
Number |
16-CC-0162 |
Sponsoring Institute |
National Institutes of Health Clinical Center (CC) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Non-English Speaking;
Children |
Keywords |
Bacteria;
Natural History |
Recruitment Keyword(s) |
None |
Condition(s) |
Alcoholic Intoxication;
Alcohol-Related Disorders |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
NIH Clinical Center |
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.
Eligibility
INCLUSION CRITERIA:
-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
EXCLUSION CRITERIA:
-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.
-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.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT02911077