Status:
COMPLETED
Probiotics, Immune Function, and the Brain in Alcohol Consumers
Lead Sponsor:
Brown University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol; Use, Problem
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
This pilot project is a brief, open-label clinical trial of probiotics as an intervention in heavy drinkers. Heavy drinkers who do not yet show significant signs of liver disease may stand to benefit ...
Detailed Description
This pilot project is a brief, open-label clinical trial of probiotics as an intervention to reduce systemic and neural inflammation in heavy drinkers. Heavy drinkers who do not yet show significant s...
Eligibility Criteria
Inclusion
- 18-64 years old;
- Able to speak and read English well enough to complete study procedures;
- Meets NIAAA guidelines for heavy drinking in the past 30 days.
Exclusion
- Chronic disease requiring daily use of medication;
- Seeking or receiving treatment for alcohol/drug use, with exception of smoking cessation;
- Self-reported history of liver disease;
- Antibiotic or probiotic use in past 1 month;
- Positive urine drug test;
- History of fainting, weakness, infection, excessive bruising, or extreme distress from blood draw;
- Safety contraindication for MRI (e.g., ferromagnetic implant in the body, claustrophobia);
- Head trauma with loss of consciousness \>10 min;
- Pregnant, breastfeeding, or not using effective birth control;
- Unable to complete the study visits due to time or scheduling constraints;
- Weight \<110 lbs.
- Conditions of immunodeficiency, such as HIV infection, primary immune deficiency, or taking immune-suppressant medications.
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05232682
Start Date
February 24 2022
End Date
August 9 2023
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Brown University
Providence, Rhode Island, United States, 02912