NCT03026231

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

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-07-15
• Primary completion: 2018-07-17
• Completion: 2018-07-17
• First posted: 2017-01-20
• Last updated: 2018-08-10

Regulatory

• FDA-regulated drug study