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NCT Number: NCT06647277

Fecal MicrobiotaTransplant for the Treatment of Parkinson's Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sabine Hazan

Ventura, California, 93003, United States

About this study

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. Subjects in the study are required to meet with the study clinician on 11 occasions: two (2) visits for informed consent and baseline assessment, one (1) visit prior to FMT for colonoscopy instructions and exam, one (1) visit for the fecal microbiota transplant procedure by colonoscopy at an outpatient surgical center, seven (7) visits for post-FMT assessment. There are also daily phone calls in the week following the FMT, and weekly phone call visits (during weeks in which there is not a physical visit) to check up on how the subject is doing, any change in medications, side effects, and answer any questions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals diagnosed with PD

Exclusion criteria

  • Non-PD individuals

Treatment and study plan

Fecal Microbiota Transplant

Combination Product

Fecal Microbiota Transplant

Other names: Vancomycin

Primary outcomes

  1. Parkinson's disease symptoms

    Time frame: 6.5 months for each subject

    Changes in symptoms reported

Secondary outcomes

  1. Alterations in Subject microbiome from baseline

    Time frame: 6.5 months for each subject

    Changes in microbiome Shannon Diversity Index and relative abundance

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Lopez

CONTACT

[email protected]

8053390549

Sponsors and collaborators

Lead sponsor

ProgenaBiome

Other

Registry information

Official study title

An Open-Label Phase I Clinical Trial of Vancomycin Followed by Fecal Microbiota Transplant for the Treatment of Parkinson's Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 17, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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