Gut Health and the Effect on Substance and Alcohol Cravings

NCT06026982 | Unknown Early Phase 1

• 1 other identifier: #23-MCCA-101
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Craving

Keywords

gut health; substance craving; alcohol craving

Outcome Measures

Primary Outcomes (1)

• Decrease in substance or alcohol cravings

  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

Study Arms (1)

Gut Health Surveys

EXPERIMENTAL

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.

Dietary Supplement: probiotic and pickle

Interventions

probiotic and pickle DIETARY_SUPPLEMENT

probiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion CFU and inulin 250mg along with a pickle

Gut Health Surveys

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• City Rescue Mission Medical Clinic: lead

MeSH Terms

Interventions

Probiotics; AT2G25170 protein, Arabidopsis

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Anna McCarthy, MD MPH

  City Rescue Mission Medical Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna M McCarthy, MD, MPH

CONTACT

9049554247; annamarie5092@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: September 7, 2023
• Study Start: September 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share