Exploring Gut-Brain and Brain-Gut Interactions in Alcohol Use Disorder Via Microbiota Investigations: A Pilot Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03152760|
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : August 27, 2018
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|
|Estimated Enrollment :||69 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|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Alcohol use disorder participants
Alcohol Use Disorder participants
- To investigate the differences in the gut microbiota in abstinence and current drinking populations with AUD, by analyzing and comparing the gut microbiota of abstinent AUD participants, Abstinent Group to that of a group of currently drinking A... [ Time Frame: 10-day time frame ]
- 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 ]
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
|Contact: Lisa A Farinelli, R.N.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Lorenzo Leggio, M.D.||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|