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Gut Health and the Effect on Substance and Alcohol Cravings

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ClinicalTrials.gov Identifier: NCT06026982
Recruitment Status : Not yet recruiting
First Posted : September 7, 2023
Last Update Posted : September 7, 2023
Sponsor:
Information provided by (Responsible Party):
Anna McCarthy, City Rescue Mission Medical Clinic

Tracking Information
First Submitted Date  ICMJE July 25, 2023
First Posted Date  ICMJE September 7, 2023
Last Update Posted Date September 7, 2023
Estimated Study Start Date  ICMJE September 2023
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2023)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gut Health and the Effect on Substance and Alcohol Cravings
Official Title  ICMJE Gut Health and the Effect on Substance and Alcohol Cravings
Brief Summary Gut health has been linked with improvement in mental health but no research has been done to evaluate if improving gut health can have an effect on alcohol and substance cravings. This pilot study is to evaluate if any decrease in cravings can be found with probiotics/prebiotics by improving gut health. Participants will take a pre-survey to evaluate their cravings. Participants 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.
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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Consent and a pre survey on cravings will be collected. Then participants will take a probiotic/prebiotic and a pickle 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Craving
Intervention  ICMJE Dietary Supplement: probiotic and pickle
probiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion CFU and inulin 250mg along with a pickle
Study Arms  ICMJE 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.
Intervention: Dietary Supplement: probiotic and pickle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2023)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Anna M McCarthy, MD, MPH 9049554247 annamarie5092@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06026982
Other Study ID Numbers  ICMJE #23-MCCA-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Anna McCarthy, City Rescue Mission Medical Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE City Rescue Mission Medical Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anna McCarthy, MD MPH City Rescue Mission Medical Clinic
PRS Account City Rescue Mission Medical Clinic
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP