Gut Health and the Effect on Substance and Alcohol Cravings
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06026982 |
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Recruitment Status :
Not yet recruiting
First Posted : September 7, 2023
Last Update Posted : September 7, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Craving | Dietary Supplement: probiotic and pickle | Early Phase 1 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| 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 |
| Official Title: | Gut Health and the Effect on Substance and Alcohol Cravings |
| Estimated Study Start Date : | September 2023 |
| Estimated Primary Completion Date : | October 2023 |
| Estimated Study Completion Date : | October 2023 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Dietary Supplement: probiotic and pickle
probiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion CFU and inulin 250mg along with a pickle |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06026982
| Contact: Anna M McCarthy, MD, MPH | 9049554247 | annamarie5092@gmail.com |
| Principal Investigator: | Anna McCarthy, MD MPH | City Rescue Mission Medical Clinic |
Documents provided by Anna McCarthy, City Rescue Mission Medical Clinic:
| Responsible Party: | Anna McCarthy, Principal Investigator, City Rescue Mission Medical Clinic |
| ClinicalTrials.gov Identifier: | NCT06026982 |
| Other Study ID Numbers: |
#23-MCCA-101 |
| First Posted: | September 7, 2023 Key Record Dates |
| Last Update Posted: | September 7, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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gut health substance craving alcohol craving |