Clinical trial NCT03026231: 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
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Parkinson's Disease
Keywords: Fecal microbiota transplantation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Kelsey Research Foundation
First posted: 2017-01-20
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index
timeFrame: 3 years
measure: Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index
timeFrame: 6 months
measure: Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index
timeFrame: 12 months
measure: Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
timeFrame: 3 years
measure: Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
timeFrame: 6 months
measure: Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
timeFrame: 12 months
measure: Most abundant Phylum in Fecal Sample
timeFrame: 3 years
measure: Most abundant Phylum in Fecal Sample
timeFrame: 6 months
measure: Most abundant Phylum in Fecal Sample
timeFrame: 12 months
Secondary outcomes:
measure: Improvements in flora diversity by oral administration of a fecal suspension from healthy donors comparing data with untreated controls
timeFrame: 3 years
measure: Number of bowel movements per day
timeFrame: 3 years
measure: Number of bowel movements per day
timeFrame: 6 months
measure: Number of bowel movements per day
timeFrame: 12 months
measure: Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: 3 years
measure: Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: 1 day
measure: Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: 6 months
measure: Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: 12 months
measure: Number of participants with a change in required anti-PD symptomatic or levodopa therapy
timeFrame: 12 months
measure: 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)
timeFrame: 3 years
measure: 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)
timeFrame: day 1 of treatment
measure: 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)
timeFrame: 6 months
measure: 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)
timeFrame: 12 months
measure: Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
timeFrame: 3 years
measure: Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
timeFrame: day 1 of treatment
measure: Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
timeFrame: 6 months
measure: Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)
timeFrame: 12 months
measure: Number of participants with worsening of PD symptoms or other potential flora-mediated disorders as indicated by patient diares
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Herbert L DuPont, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.