NCT03671785

Study of the Fecal Microbiome in Patients With Parkinson's Disease

A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the intestinal microbiome in subjects with Parkinson's disease and to determine safety and trends in improvements in diversity of colonic microbiome following administration of lyophilized PRIM-DJ2727

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	PRIM-DJ2727	Twice filtered fecal microbiota product from three screened healthy donors will be lyophilized and encapsulated in enteric-coated capsules. Each dose of enteric coated capsules consists of 60 grams of stool and will be administered orally twice-weekly for 12 consecutive weeks
DRUG	Placebo oral capsule	Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria. The placebo will consist of Lactose (spray-dried United States Pharmacopeia (USP) 64.385gm), food color, powdered Black, Brown, and Yellow in the enteric capsules. Placebo will be administered orally twice-weekly for 12 consecutive weeks

Timeline

• Start date: 2019-05-15
• Primary completion: 2022-10-09
• Completion: 2022-10-12
• First posted: 2018-09-14
• Last updated: 2023-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study