Last reviewed · How we verify

NCT03671785

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

Completed Phase 1 Last updated 24 May 2023
What this trial tests

Phase 1 trial testing PRIM-DJ2727 in Parkinson Disease in 15 participants. Completed in 12 October 2022.

Timeline
15 May 2019
Primary endpoint
9 October 2022
12 October 2022

Quick facts

Lead sponsorThe University of Texas Health Science Center, Houston
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment15
Start date15 May 2019
Primary completion9 October 2022
Estimated completion12 October 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Adults 55 to 75, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Microbiota-gut-brain axis and its therapeutic applications in neurodegenerative diseases.
    Loh JS, Mak WQ, Tan LKS, Ng CX, et al · · 2024 · cited 631× · PMID 38360862 · DOI 10.1038/s41392-024-01743-1
  2. Fecal microbiota transplantation beyond Clostridioides difficile infections.
    Wortelboer K, Nieuwdorp M, Herrema H. · · 2019 · cited 111× · PMID 31201141 · DOI 10.1016/j.ebiom.2019.05.066
  3. Fecal microbiota transplantation in Parkinson's disease-A randomized repeat-dose, placebo-controlled clinical pilot study.
    DuPont HL, Suescun J, Jiang ZD, Brown EL, et al · · 2023 · cited 98× · PMID 36937520 · DOI 10.3389/fneur.2023.1104759
  4. Fecal Microbiota Transplantation: A New Therapeutic Attempt from the Gut to the Brain.
    Xu HM, Huang HL, Zhou YL, Zhao HL, et al · · 2021 · cited 59× · PMID 33510784 · DOI 10.1155/2021/6699268
  5. The Gut Microbiota in Parkinson Disease: Interactions with Drugs and Potential for Therapeutic Applications.
    Menozzi E, Schapira AHV. · · 2024 · cited 22× · PMID 38570412 · DOI 10.1007/s40263-024-01073-4
  6. Therapies for Parkinson's disease and the gut microbiome: evidence for bidirectional connection.
    Hey G, Nair N, Klann E, Gurrala A, et al · · 2023 · cited 17× · PMID 37323145 · DOI 10.3389/fnagi.2023.1151850
  7. The Gut-Brain Axis in Parkinson disease: Emerging Concepts and Therapeutic Implications.
    Menozzi E, Schapira AHV, Borghammer P. · · 2025 · cited 11× · PMID 40079755 · DOI 10.1002/mdc3.70029
  8. Recent advances in understanding and treatment of Parkinson's disease.
    Tarakad A, Jankovic J. · · 2020 · cited 10× · PMID 33659938 · DOI 10.12703/b/9-6

Verify or expand the search:

Other trials of PRIM-DJ2727

Trials testing the same drug.

Other recruiting trials for Parkinson Disease

Currently open trials in the same condition.

Other The University of Texas Health Science Center, Houston trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03671785.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing