NCT06647277

Brief Summary

FMT may significantly improve quality of life and Parkinson Disease (PD) symptom severity measurements. We hypothesize that gut microbial dysbiosis is a major contributing factor in Parkinson's disease.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 parkinson-disease

Timeline
17mo left

Started Jul 2026

Typical duration for phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

October 8, 2024

Last Update Submit

June 23, 2025

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Parkinson's disease symptoms

    Changes in symptoms reported

    6.5 months for each subject

Secondary Outcomes (1)

  • Alterations in Subject microbiome from baseline

    6.5 months for each subject

Study Arms (1)

PD patients

OTHER

This is an open-label clinical trial to evaluate the Safety of fecal microbiota transplant following a 10 day treatment with Vancomycin in adult subjects with Parkinson's disease.

Combination Product: Fecal Microbiota Transplant

Interventions

Fecal Microbiota TransplantCOMBINATION_PRODUCT

Fecal Microbiota Transplant

Also known as: Vancomycin
PD patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals diagnosed with PD

You may not qualify if:

  • Non-PD individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sabine Hazan

Ventura, California, 93003, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Fecal Microbiota TransplantationVancomycin

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Alex Lopez

CONTACT

8053390549alex@progenabiome.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 17, 2024

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)