CravingEarly Phase 1NCT06026982
Gut Health and the Effect on Substance and Alcohol Cravings
A Early Phase 1 study testing probiotic and pickle in people with Craving, run by City Rescue Mission Medical Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Craving
- What is being tested?
- probiotic and pickle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Oct 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Craving
- Being tested
- probiotic and pickle
- Keywords
- gut health, substance craving, alcohol craving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic and pickleDietary supplement
probiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion CFU and inulin 250mg along with a pickle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: probiotic and pickle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CravingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City Rescue Mission Medical Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna McCarthy, City Rescue Mission Medical Clinic
- Investigators
- Anna McCarthy, MD MPH, Principal investigator, City Rescue Mission Medical Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026982
- Sponsor's protocol ID
- #23-MCCA-101
- Status last verified
- Sep 2023
- First submitted
- 25 Jul 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Health and the Effect on Substance and Alcohol Cravings
- ClinicalTrials.gov ID
- NCT06026982
- Acronym / sponsor ID
- #23-MCCA-101
- Conditions
- Craving
- Keywords
- gut health, substance craving, alcohol craving
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- City Rescue Mission Medical ClinicUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gut Health Surveys | Experimental | Dietary Supplement: probiotic and pickleParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotic and pickleprobiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion CFU and inulin 250mg along with a pickle | Dietary supplement | Gut Health Surveys |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna McCarthy, MD MPH principal investigator
City Rescue Mission Medical Clinic
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing probiotic and pickle in people with Craving, run by City Rescue Mission Medical Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna M McCarthy, MD, MPH (9049554247, annamarie5092@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in substance or alcohol cravings (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.