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Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients

Primary Purpose

Parkinson's Disease

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
PRIM-DJ2727
Placebo (for PRIM-DJ2727)
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Fecal microbiota transplantation

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis PD with a Hoehn and Yahr stage of < 3 in the "Off medicine" state
  • Sexually active male and female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period
  • Female subjects of child-bearing potential must have a negative pregnancy test in the 72 hours before the procedure
  • Subject willing to sign an informed consent form
  • Subject deemed likely to survive for ≥ 1 year after enrolment
  • Subject's attending physician will refer and provide non-transplant care for the subject
  • Subjects must demonstrate adherence to and the ability to maintain a Parkinson's therapy medical regimen that is stable for 90 days before enrolment and participation in the study.

Exclusion Criteria:

  • Greater than 20 grams of ethanol intake daily
  • Unstable Parkinson's disease
  • Other immune disorder or clinical immunosuppression
  • Probiotic used during study period
  • Severe underlying disease such that the subject is not expected to survive for one or more years or unstable medical condition requiring frequent change in treatments
  • Current or recent within one month receipt of an antibiotic with expected activity against enteric bacteria
  • Prior Deep Brain Stimulation, or surgical intervention for PD , intravenous glutathione therapy or stem cell therapy
  • HIV or Hepatitis B / C positive

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    PRIM-DJ2727

    Placebo

    Arm Description

    Subjects with PD will be randomly assigned to receive PRIM-DJ2727 in orally administered enteric-coated capsules

    Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules

    Outcomes

    Primary Outcome Measures

    Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index
    Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index
    Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index
    Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
    Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
    Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
    Most abundant Phylum in Fecal Sample
    Most abundant Phylum in Fecal Sample
    Most abundant Phylum in Fecal Sample

    Secondary Outcome Measures

    Improvements in flora diversity by oral administration of a fecal suspension from healthy donors comparing data with untreated controls
    Number of bowel movements per day
    Number of bowel movements per day
    Number of bowel movements per day
    Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.
    Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.
    Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.
    Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.
    Number of participants with a change in required anti-PD symptomatic or levodopa therapy
    Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)
    Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)
    Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)
    Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)
    Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
    Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
    Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
    Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
    Number of participants with worsening of PD symptoms or other potential flora-mediated disorders as indicated by patient diares

    Full Information

    First Posted
    January 11, 2017
    Last Updated
    August 8, 2018
    Sponsor
    The University of Texas Health Science Center, Houston
    Collaborators
    Kelsey Research Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03026231
    Brief Title
    Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients
    Official Title
    A Prospective, Randomized Placebo Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Weekly Administration of Lyophilized PRIM-DJ2727 Given Orally in Subjects With Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    study will be started under a new modified protocol
    Study Start Date
    July 15, 2017 (Anticipated)
    Primary Completion Date
    July 17, 2018 (Actual)
    Study Completion Date
    July 17, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Texas Health Science Center, Houston
    Collaborators
    Kelsey Research Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to characterize the intestinal flora in subjects with Parkinson's Disease (PD) and to determine safety and trends in improvements in diversity of colonic microbiome following fecal microbiota transplantation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease
    Keywords
    Fecal microbiota transplantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PRIM-DJ2727
    Arm Type
    Active Comparator
    Arm Description
    Subjects with PD will be randomly assigned to receive PRIM-DJ2727 in orally administered enteric-coated capsules
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules
    Intervention Type
    Biological
    Intervention Name(s)
    PRIM-DJ2727
    Intervention Description
    Thirty eligible subjects with PD will be randomly assigned to receive either PRIM-DJ2727 in orally administered enteric-coated capsules or placebo capsules
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo (for PRIM-DJ2727)
    Intervention Description
    Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules
    Primary Outcome Measure Information:
    Title
    Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index
    Time Frame
    3 years
    Title
    Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index
    Time Frame
    6 months
    Title
    Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index
    Time Frame
    12 months
    Title
    Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
    Time Frame
    3 years
    Title
    Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
    Time Frame
    6 months
    Title
    Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
    Time Frame
    12 months
    Title
    Most abundant Phylum in Fecal Sample
    Time Frame
    3 years
    Title
    Most abundant Phylum in Fecal Sample
    Time Frame
    6 months
    Title
    Most abundant Phylum in Fecal Sample
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Improvements in flora diversity by oral administration of a fecal suspension from healthy donors comparing data with untreated controls
    Time Frame
    3 years
    Title
    Number of bowel movements per day
    Time Frame
    3 years
    Title
    Number of bowel movements per day
    Time Frame
    6 months
    Title
    Number of bowel movements per day
    Time Frame
    12 months
    Title
    Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
    Description
    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.
    Time Frame
    3 years
    Title
    Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
    Description
    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.
    Time Frame
    1 day
    Title
    Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
    Description
    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.
    Time Frame
    6 months
    Title
    Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
    Description
    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.
    Time Frame
    12 months
    Title
    Number of participants with a change in required anti-PD symptomatic or levodopa therapy
    Time Frame
    12 months
    Title
    Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)
    Time Frame
    3 years
    Title
    Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)
    Time Frame
    day 1 of treatment
    Title
    Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)
    Time Frame
    6 months
    Title
    Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39)
    Time Frame
    12 months
    Title
    Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
    Time Frame
    3 years
    Title
    Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
    Time Frame
    day 1 of treatment
    Title
    Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
    Time Frame
    6 months
    Title
    Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
    Time Frame
    12 months
    Title
    Number of participants with worsening of PD symptoms or other potential flora-mediated disorders as indicated by patient diares
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis PD with a Hoehn and Yahr stage of < 3 in the "Off medicine" state Sexually active male and female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period Female subjects of child-bearing potential must have a negative pregnancy test in the 72 hours before the procedure Subject willing to sign an informed consent form Subject deemed likely to survive for ≥ 1 year after enrolment Subject's attending physician will refer and provide non-transplant care for the subject Subjects must demonstrate adherence to and the ability to maintain a Parkinson's therapy medical regimen that is stable for 90 days before enrolment and participation in the study. Exclusion Criteria: Greater than 20 grams of ethanol intake daily Unstable Parkinson's disease Other immune disorder or clinical immunosuppression Probiotic used during study period Severe underlying disease such that the subject is not expected to survive for one or more years or unstable medical condition requiring frequent change in treatments Current or recent within one month receipt of an antibiotic with expected activity against enteric bacteria Prior Deep Brain Stimulation, or surgical intervention for PD , intravenous glutathione therapy or stem cell therapy HIV or Hepatitis B / C positive
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Herbert L DuPont, MD
    Organizational Affiliation
    The University of Texas Health Science Center, Houston
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23852569
    Citation
    Borody TJ, Paramsothy S, Agrawal G. Fecal microbiota transplantation: indications, methods, evidence, and future directions. Curr Gastroenterol Rep. 2013 Aug;15(8):337. doi: 10.1007/s11894-013-0337-1.
    Results Reference
    background
    PubMed Identifier
    23712625
    Citation
    Fasano A, Bove F, Gabrielli M, Petracca M, Zocco MA, Ragazzoni E, Barbaro F, Piano C, Fortuna S, Tortora A, Di Giacopo R, Campanale M, Gigante G, Lauritano EC, Navarra P, Marconi S, Gasbarrini A, Bentivoglio AR. The role of small intestinal bacterial overgrowth in Parkinson's disease. Mov Disord. 2013 Aug;28(9):1241-9. doi: 10.1002/mds.25522. Epub 2013 May 27.
    Results Reference
    background
    PubMed Identifier
    26428310
    Citation
    Nakane S, Yoshioka M, Oda N, Tani T, Chida K, Suzuki M, Funakawa I, Inukai A, Hasegawa K, Kuroda K, Mizoguchi K, Shioya K, Sonoda Y, Matsuo H. The characteristics of camptocormia in patients with Parkinson's disease: A large cross-sectional multicenter study in Japan. J Neurol Sci. 2015 Nov 15;358(1-2):299-303. doi: 10.1016/j.jns.2015.09.015. Epub 2015 Sep 8.
    Results Reference
    background

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    Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients

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