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

NCT03026231 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: UT-SPH/KRF FMT-2016-PD-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease

Keywords

Fecal microbiota transplantation

Outcome Measures

Primary Outcomes (9)

• Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index

  3 years

• Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index

  6 months

• Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index

  12 months

• Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant

  3 years

• Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant

  6 months

• Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant

  12 months

• Most abundant Phylum in Fecal Sample

  3 years

• Most abundant Phylum in Fecal Sample

  6 months

• Most abundant Phylum in Fecal Sample

  12 months

Secondary Outcomes (18)

• Improvements in flora diversity by oral administration of a fecal suspension from healthy donors comparing data with untreated controls

  3 years

• Number of bowel movements per day

  3 years

• Number of bowel movements per day

  6 months

• Number of bowel movements per day

  12 months

• Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  3 years

Study Arms (2)

PRIM-DJ2727

ACTIVE COMPARATOR

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

Biological: PRIM-DJ2727

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo (for PRIM-DJ2727)

Interventions

PRIM-DJ2727 BIOLOGICAL

Thirty eligible subjects with PD will be randomly assigned to receive either PRIM-DJ2727 in orally administered enteric-coated capsules or placebo capsules

PRIM-DJ2727

Placebo (for PRIM-DJ2727) DRUG

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

Placebo

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Kelsey Research Foundation: collaborator

Related Publications (3)

• 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.

  PMID: 23852569 BACKGROUND

• 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.

  PMID: 23712625 BACKGROUND

• 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.

  PMID: 26428310 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Herbert L DuPont, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 20, 2017
• Study Start: July 15, 2017
• Primary Completion: July 17, 2018
• Study Completion: July 17, 2018
• Last Updated: August 10, 2018

Record last verified: 2018-08