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NCT03671785
Study of the Fecal Microbiome in Patients With Parkinson's Disease
Phase 1 trial testing PRIM-DJ2727 in Parkinson Disease in 15 participants. Completed in 12 October 2022.
9 October 2022
Quick facts
| Lead sponsor | The University of Texas Health Science Center, Houston |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 15 May 2019 |
| Primary completion | 9 October 2022 |
| Estimated completion | 12 October 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PRIM-DJ2727 — full drug profile →
- Placebo oral capsule
Conditions studied
- Parkinson Disease — all drugs for Parkinson Disease →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03671785
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PRIM-DJ2727
Trials testing the same drug.
- NCT06827977 — A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Sys · Phase 2 · recruiting
- NCT04371653 — A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the · Phase 2 · withdrawn
- NCT04373473 — Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of · Phase 2 · recruiting
- NCT04729790 — Randomized Clinical Trial of Standard FMT Treatments · Phase 2 · withdrawn
- NCT03026231 — Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients · Phase 1, PHASE2 · withdrawn
Other recruiting trials for Parkinson Disease
Currently open trials in the same condition.
- NCT07399496 — Accelerated TMS for Apathy in PD · NA · recruiting
- NCT07371338 — Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients · Phase 1 · recruiting
- NCT07442370 — The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients · NA · recruiting
- NCT06848205 — Percept Transitions in FOG and PD · NA · recruiting
- NCT07432958 — A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (P · Phase 2 · recruiting
Other The University of Texas Health Science Center, Houston trials
Trials by the same sponsor.
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- NCT07225062 — Improving HIV Prevention and Substance Use Post-Sexual Assault Services · NA · not yet recruiting
- NCT07396974 — Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT) · NA · not yet recruiting
- NCT07170163 — Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families · NA · not yet recruiting
- NCT06915441 — Lipid Infusions to Optimize Nutrition Trial · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03671785 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center, Houston
- Last refreshed: 24 May 2023
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