Exploring Gut-Brain and Brain-Gut Interactions in Alcohol Use Disorder Via Microbiota Investigations: A Pilot Study
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Observational

Summary: 
      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.

      ...
    

Detailed description: 
      Objective:

      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.

      Study population:

      Alcohol use disorder participants (current drinkers and abstinent) and healthy controls.

      Study Design:

      Between subject, observational study

      Outcome measures:

      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.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male or female individuals 21-70 years old Individuals may come to the NIH/NIAAA from a
        variety of community settings ranging from primary residences, shelters and/or other health
        care facilities
      
Keywords: Alcoholism; Healthy Volunteers; Craving; Gut; Natural History