Longitudinal Changes in the Oral and Gut Microbiome of Individuals With Alcohol Dependence (NCT02911077) | Clinical Trial Compass
CompletedNot Applicable
Longitudinal Changes in the Oral and Gut Microbiome of Individuals With Alcohol Dependence
United States23 participantsStarted 2016-09-27
Plain-language 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.
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Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identification of bacteria in the gut and oral microbiomes over time
Timeframe: all timepoints
Trial details
NCT IDNCT02911077
SponsorNational Institutes of Health Clinical Center (CC)