- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06026982
Gut Health and the Effect on Substance and Alcohol Cravings
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Consent and a pre survey on cravings will be collected. Then participants will take a probiotic/prebiotic and a pickle for 30 days. Participants will be given a probiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion colony forming unit and inulin 250mg along with a pickle daily for 30 days. After 30 days the same survey will be taken by the participants and a paired t test will be used to analyze if there is a statistical change in cravings. Participants will be in a recovery program with a prior history of substance or alcohol abuse and will be abstaining from drugs and alcohol.
The purpose of the study is to evaluate if improving gut health by the above intervention can also decrease substance and alcohol cravings. Probiotics and prebiotics have been shown to improve mental health with a decrease in depression and PTSD but no studies have investigated if improving gut health can decrease substance or alcohol cravings. Probiotics are a cheap intervention that many recovery centers with limited recourses would be able to use. Fermented foods like pickles have been shown to have significant benefit to gut health with improvement in the gut biome. Pickles are also affordable which is why this combination was chosen to be studied.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Anna M McCarthy, MD, MPH
- Phone Number: 9049554247
- Email: annamarie5092@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males and females age 18-75 years old
- current cravings for substance or alcohol use
- enrolled in a recovery clinic
- able to understand and comply with the requirements of the study
- provision of written informed consent.
Exclusion Criteria:
- Any alcohol or substance use in the past week
- any narcotic use (including methadone and buprenorphine)
- daily probiotic product use in the last 2 weeks
- women who are pregnant or planning to become pregnant during the trial
- if they already have no alcohol or substance cravings
- non English speakers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gut Health Surveys
Participants will take a pre-survey to evaluate their cravings.
They will then be started on a regimen of probiotic and prebiotic with a pickle daily for 30 days to improve gut health.
Then participants will take the same survey to evaluate if there has been any decrease in cravings.
|
probiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion CFU and inulin 250mg along with a pickle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in substance or alcohol cravings
Time Frame: 30 days
|
Evaluation via the same survey before and after probiotic and a pickle for 30 days to see if there is any change in cravings. A pre and post survey will be administered with cravings rated with a scale of 1-5, no cravings would be the number one to extreme cravings with a number of 5. A paired t-test will then be used to analyze the data. |
30 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anna McCarthy, MD MPH, City Rescue Mission Medical Clinic
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- #23-MCCA-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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