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Withdrawn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
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Fecal microbiota transplantation
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
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
NCT ID
NCT03026231
First Posted
January 11, 2017
Last Updated
August 8, 2018
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Kelsey Research Foundation
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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