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Probiotic

PRIM-DJ2727 for Parkinson's Disease

Phase 1
Waitlist Available
Led By Herbert L DuPont, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is able to maintain a stable Parkinson's therapy medical regimen during participation in the study.
Robust response to dopaminergic therapy (defined as greater than 33% reduction in symptoms (on the Unified Parkinson's Disease Rating Scale part III (UPDRS-III)) when measured in the ON medicine state compared to OFF state.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 9
Awards & highlights

Study Summary

This trial will study the effects of a new drug on the gut microbiome of people with Parkinson's disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Subjects in the study were able to maintain a stable Parkinson's therapy medical regimen.
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The study found that dopaminergic therapy resulted in a robust response 34% of the time.
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The subject has a history of being constipated.
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The subject has an attending physician who will provide care for them that is not related to their transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Any untoward medical occurrence after fecal microbiota transplantation (FMT)
Microbiome Diversity in Fecal Samples as Indicated by the Shannon Diversity Index
Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant
Secondary outcome measures
Anxiety as assessed by the Parkinson Anxiety Scale (PAS)
Change in Sense of Smell as assessed by the University of Pennsylvania Smell Identification Test (UPSIT)
Change in colon transit time (CTT) as assessed by the Smart Pill® (SP) Wireless pH/pressure recording capsule
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo groupExperimental Treatment1 Intervention
Group II: Active group treated with healthy fecal microbiotaExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo oral capsule
2010
Completed Phase 4
~2380
PRIM-DJ2727
2019
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
321,156 Total Patients Enrolled
Kelsey Research FoundationOTHER
5 Previous Clinical Trials
1,012 Total Patients Enrolled
Herbert L DuPont, MDPrincipal InvestigatorUniversity of Texas Health Science Center School of Public Health
5 Previous Clinical Trials
161 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
65+
What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Met criteria
~3 spots leftby Mar 2025