Exploring Gut-Brain and Brain-Gut Interactions in Alcohol Use Disorder Via Microbiota Investigations: A Pilot Study
Completed
Conditions studied: Alcoholism
In brief
Background: Alcohol use disorder (AUD) affects about 10 percent of people in the U.S. Studies show a relationship between the bacteria (microbiota) in the gut and the brain. Researchers think this may influence AUD. They want to learn more about changes in gut bacteria that may occur in people with AUD. Objectives: To study gut microbiota differences in current drinking versus abstinent people with AUD. Also to test if gut microbiota are related to alcohol cue-induced craving. Eligibility: People ages 21-70 who have AUD (both abstinent and current heavy drinkers) or are healthy, moderate drinkers Design: Participants will be screened in Protocol 14-AA-0181. Participants will have a first visit. They will have 4 more visits within about 10 days. Visits include: Fecal sample collection Physical exam Blood tests Assessment of diet and alcohol use X-rays to test body composition, They will sit under a ventilation hood to measure metabolism. They must fast 12 hours before this test. They will drink a solution. Their urine is collected over 5 hours. Ultrasound of the liver area. They must fast overnight before this test. At 2 visits, they will be in a bar-like setting. They will be exposed to stimuli associated with eating and drinking. They will rate their urge to drink alcohol and their food cravings. Participants will collect their stool throughout the study. They will also record information about their diet and daily activities like sleep and exercise. At the end of the study, participants will discuss their drinking. They will receive counseling if needed.
Key facts
- Study ID
- NCT03152760
- Run by
- National Institute on Drug Abuse (NIDA)
- People needed
- 35
- Starts
- 2017-08-28
- Expected to finish
- 2020-11-24
- Last updated by the study team
- 2026-07-22
Who can join
Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Exclusion - All Participants (at the time subject are evaluated for this protocol)
- Current pregnancy or lactation
- Positive Urine Drug Test for illegal drugs
- Body Mass Index (BMI) less than or equal to 18.5 kg/m(2) or BMI greater than or equal to 40 kg/m(2)
- Presence of active implantable electronic devices (e.g., defribillators, pumps, pacemakers)
- Current medical history of the following medical conditions:
- -diabetes; chronic gut inflammatory diseases; GI or any other type of cancer; short bowel syndrome; conditions requiring parenteral nutrition;
- Diarrhea or other symptoms of possible enteritis in the past 7 days (self-reported)
- Recent history of sigmoidoscopy or colonoscopy (past 30 days)
- Current use (past 90 days) of the following medications:
- -oral antimicrobials (specifcally: antiviral, antifungal, or antibiotics); prebiotics; probiotics; laxatives; antispasmodic drugs; oral, IM or IV steroids
- Any other reason or clinical condition that the PI, or Medical Advisory Investigator (MAI) considers unsafe or not in the best interest of the study research integrity
- If any answer is Yes , subject may not be enrolled.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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