xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06026982</url>
    </required_header>
    <id_info>
      <org_study_id>#23-MCCA-101</org_study_id>
      <nct_id>NCT06026982</nct_id>
    </id_info>
    <brief_title>Gut Health and the Effect on Substance and Alcohol Cravings</brief_title>
    <official_title>Gut Health and the Effect on Substance and Alcohol Cravings</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>City Rescue Mission Medical Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>City Rescue Mission Medical Clinic</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Gut health has been linked with improvement in mental health but no research has been done to&#xD;
        evaluate if improving gut health can have an effect on alcohol and substance cravings. This&#xD;
        pilot study is to evaluate if any decrease in cravings can be found with&#xD;
        probiotics/prebiotics by improving gut health. Participants will take a pre-survey to&#xD;
        evaluate their cravings. Participants will then be started on a regimen of probiotic and&#xD;
        prebiotic with a pickle daily for 30 days to improve gut health. Then participants will take&#xD;
        the same survey to evaluate if there has been any decrease in cravings.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Consent and a pre survey on cravings will be collected. Then participants will take a&#xD;
        probiotic/prebiotic and a pickle for 30 days. Participants will be given a probiotic formula&#xD;
        by Rugby Health that has Bacillus Coagulans spores 1billion colony forming unit and inulin&#xD;
        250mg along with a pickle daily for 30 days. After 30 days the same survey will be taken by&#xD;
        the participants and a paired t test will be used to analyze if there is a statistical change&#xD;
        in cravings. Participants will be in a recovery program with a prior history of substance or&#xD;
        alcohol abuse and will be abstaining from drugs and alcohol.&#xD;
  &#xD;
        The purpose of the study is to evaluate if improving gut health by the above intervention can&#xD;
        also decrease substance and alcohol cravings. Probiotics and prebiotics have been shown to&#xD;
        improve mental health with a decrease in depression and PTSD but no studies have investigated&#xD;
        if improving gut health can decrease substance or alcohol cravings. Probiotics are a cheap&#xD;
        intervention that many recovery centers with limited recourses would be able to use.&#xD;
        Fermented foods like pickles have been shown to have significant benefit to gut health with&#xD;
        improvement in the gut biome. Pickles are also affordable which is why this combination was&#xD;
        chosen to be studied.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <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.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Decrease in substance or alcohol cravings</measure>
      <time_frame>30 days</time_frame>
      <description>Evaluation via the same survey before and after probiotic and a pickle for 30 days to see if there is any change in cravings.&#xD;
  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.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Craving</condition>
    <arm_group>
      <arm_group_label>Gut Health Surveys</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>probiotic and pickle</intervention_name>
      <description>probiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion CFU and inulin 250mg along with a pickle</description>
      <arm_group_label>Gut Health Surveys</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males and females age 18-75 years old&#xD;
  &#xD;
            -  current cravings for substance or alcohol use&#xD;
  &#xD;
            -  enrolled in a recovery clinic&#xD;
  &#xD;
            -  able to understand and comply with the requirements of the study&#xD;
  &#xD;
            -  provision of written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any alcohol or substance use in the past week&#xD;
  &#xD;
            -  any narcotic use (including methadone and buprenorphine)&#xD;
  &#xD;
            -  daily probiotic product use in the last 2 weeks&#xD;
  &#xD;
            -  women who are pregnant or planning to become pregnant during the trial&#xD;
  &#xD;
            -  if they already have no alcohol or substance cravings&#xD;
  &#xD;
            -  non English speakers.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anna McCarthy, MD MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>City Rescue Mission Medical Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anna M McCarthy, MD, MPH</last_name>
      <phone>9049554247</phone>
      <email>annamarie5092@gmail.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>City Rescue Mission Medical Clinic</investigator_affiliation>
      <investigator_full_name>Anna McCarthy</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>gut health</keyword>
    <keyword>substance craving</keyword>
    <keyword>alcohol craving</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>August 10, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT06026982/Prot_SAP_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>February 22, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT06026982/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06026982
  org study id: #23-MCCA-101
  nct id: NCT06026982
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  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.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Decrease in substance or alcohol cravings
  time frame: 30 days
  description: 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.
  arm group label: Gut Health Surveys
  arm group type: Experimental
  description: 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 type: Dietary Supplement
  intervention name: probiotic and pickle
  description: probiotic formula by Rugby Health that has Bacillus Coagulans spores 1billion CFU and inulin 250mg along with a pickle
  arm group label: Gut Health Surveys
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Anna McCarthy, MD MPH
  role: Principal Investigator
  affiliation: City Rescue Mission Medical Clinic
  last name: Anna M McCarthy, MD, MPH
  phone: 9049554247
  email: annamarie5092@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: City Rescue Mission Medical Clinic
  investigator full name: Anna McCarthy
  investigator title: Principal Investigator
  sharing ipd: No
  provided document: 
  provided document: 