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

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ClinicalTrials.gov Identifier: NCT03026231
Recruitment Status : Withdrawn (study will be started under a new modified protocol)
First Posted : January 20, 2017
Last Update Posted : August 10, 2018
Sponsor:
Collaborator:
Kelsey Research Foundation
Information provided by (Responsible Party):
Herbert DuPont, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Biological: PRIM-DJ2727 Drug: Placebo (for PRIM-DJ2727) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 15, 2017
Actual Primary Completion Date : July 17, 2018
Actual Study Completion Date : July 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PRIM-DJ2727
Subjects with PD will be randomly assigned to receive PRIM-DJ2727 in orally administered enteric-coated capsules
Biological: PRIM-DJ2727
Thirty eligible subjects with PD will be randomly assigned to receive either PRIM-DJ2727 in orally administered enteric-coated capsules or placebo capsules

Placebo Comparator: Placebo
Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules
Drug: Placebo (for PRIM-DJ2727)
Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules




Primary Outcome Measures :
  1. Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index [ Time Frame: 3 years ]
  2. Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index [ Time Frame: 6 months ]
  3. Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index [ Time Frame: 12 months ]
  4. Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant [ Time Frame: 3 years ]
  5. Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant [ Time Frame: 6 months ]
  6. Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant [ Time Frame: 12 months ]
  7. Most abundant Phylum in Fecal Sample [ Time Frame: 3 years ]
  8. Most abundant Phylum in Fecal Sample [ Time Frame: 6 months ]
  9. Most abundant Phylum in Fecal Sample [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Improvements in flora diversity by oral administration of a fecal suspension from healthy donors comparing data with untreated controls [ Time Frame: 3 years ]
  2. Number of bowel movements per day [ Time Frame: 3 years ]
  3. Number of bowel movements per day [ Time Frame: 6 months ]
  4. Number of bowel movements per day [ Time Frame: 12 months ]
  5. Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: 3 years ]
    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.

  6. Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: 1 day ]
    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.

  7. Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: 6 months ]
    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.

  8. Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: 12 months ]
    The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.

  9. Number of participants with a change in required anti-PD symptomatic or levodopa therapy [ Time Frame: 12 months ]
  10. 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 ]
  11. 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 ]
  12. 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 ]
  13. 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 ]
  14. Memory as assessed by score on the Montreal Cognitive Assessment (MoCA) [ Time Frame: 3 years ]
  15. Memory as assessed by score on the Montreal Cognitive Assessment (MoCA) [ Time Frame: day 1 of treatment ]
  16. Memory as assessed by score on the Montreal Cognitive Assessment (MoCA) [ Time Frame: 6 months ]
  17. Memory as assessed by score on the Montreal Cognitive Assessment (MoCA) [ Time Frame: 12 months ]
  18. Number of participants with worsening of PD symptoms or other potential flora-mediated disorders as indicated by patient diares [ Time Frame: 12 months ]


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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT03026231


Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Kelsey Research Foundation
Investigators
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Principal Investigator: Herbert L DuPont, MD The University of Texas Health Science Center, Houston

Publications:
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Responsible Party: Herbert DuPont, Professor of Medicine, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03026231     History of Changes
Other Study ID Numbers: UT-SPH/KRF FMT-2016-PD-01
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Herbert DuPont, The University of Texas Health Science Center, Houston:
Fecal microbiota transplantation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases