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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03026231
• Other study ID #: UT-SPH/KRF FMT-2016-PD-01
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: July 15, 2017
• Est. completion date: July 17, 2018

Study information

• Verified date: August 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Kelsey Research Foundation

References & 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index		3 years
Primary	Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index		6 months
Primary	Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index		12 months
Primary	Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant		3 years
Primary	Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant		6 months
Primary	Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant		12 months
Primary	Most abundant Phylum in Fecal Sample		3 years
Primary	Most abundant Phylum in Fecal Sample		6 months
Primary	Most abundant Phylum in Fecal Sample		12 months
Secondary	Improvements in flora diversity by oral administration of a fecal suspension from healthy donors comparing data with untreated controls		3 years
Secondary	Number of bowel movements per day		3 years
Secondary	Number of bowel movements per day		6 months
Secondary	Number of bowel movements per day		12 months
Secondary	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.	3 years
Secondary	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.	1 day
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	Number of participants with a change in required anti-PD symptomatic or levodopa therapy		12 months
Secondary	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)		3 years
Secondary	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)		day 1 of treatment
Secondary	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)		6 months
Secondary	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)		12 months
Secondary	Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)		3 years
Secondary	Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)		day 1 of treatment
Secondary	Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)		6 months
Secondary	Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)		12 months
Secondary	Number of participants with worsening of PD symptoms or other potential flora-mediated disorders as indicated by patient diares		12 months