Exploring Gut-Brain and Brain-Gut Interactions in Alcohol Use Disorder Via Microbiota Investigations: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT03152760|
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : November 30, 2020
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.
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.
People ages 21-70 who have AUD (both abstinent and current heavy drinkers) or are healthy, moderate drinkers
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
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.
|Condition or disease|
An increasing body of preclinical literature suggests a role of the gut microbiota in a wide range of medical disorders, including neuropsychiatric diseases like autism, anxiety, and depression. Preliminary studies have reported alterations in microbiota composition, inflammation, and intestinal permeability in alcohol-dependent patients. However, there is little research on the association between these alterations and behavioral outcomes associated with alcohol use disorder (AUD), such as alcohol craving and drinking. The main goal is to investigate gut microbiota differences in current drinking versus abstinent individuals with AUD, and whether microbial profiles are correlated with alcohol cue-induced craving. Finally, another goal of this project will be to conduct preliminary translational bed-to-bench work using rodent models of excessive alcohol use via collaborations with basic science laboratories.
Alcohol use disorder participants (current drinkers and abstinent) and healthy controls.
Between subject, observational study
We will compare the gut microbiota of AUD participants who have been abstinent to that of current drinkers. In addition, we will further compare the gut microbiota of these two groups to a third group of healthy controls with no prior or current diagnosis of AUD. The secondary aim of this study is to examine whether the overall microbial community composition, function and individual taxa correlate with alcohol cue-induced craving.
|Study Type :||Observational|
|Actual Enrollment :||35 participants|
|Official Title:||Exploring Gut-Brain and Brain-Gut Interactions in Alcohol Use Disorder Via Microbiota Investigations: A Pilot Study|
|Actual Study Start Date :||August 28, 2017|
|Actual Primary Completion Date :||March 4, 2020|
|Actual Study Completion Date :||November 24, 2020|
Abstinent Group (AB)
Current AUD diagnosis, currently abstaining from alcohol
Current Drinking Group (CD)
Current AUD diagnosis, not seeking AUD treatment
Healthy Control Group (HC)
NO current or past AUD diagnosis
- Observed differences in composition and function of microbiome between cohorts [ Time Frame: 10-day time frame ]To investigate the primary aim, participants' gut microbiota will be collected and analyzed to compare the three groups.
- The secondary aims will be to examine whether participants' gut microbiota composition is associated with biobehavioral correlates as alcohol cue- induced craving during a Cue-reactivity procedure. [ Time Frame: 10-day time frame ]1.To examine whether participants' gut microbiota composition is associated with biobehavioral correlates as alcohol cue-induced craving during a Cue-reactivity procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152760
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Lorenzo Leggio, M.D.||National Institute on Drug Abuse (NIDA)|