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Levodopa Response and Gut Microbiome in Patients With Parkinson's Disease

NCT04956939 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2022-11-07

No results posted yet for this study

Summary

Levodopa (LD) is an effective treatment to control symptoms of Parkinson's disease (PD). However, the response to (the effectiveness) LD changes over time and patients require higher and more frequent LD doses for treatment. The purpose of this study is to identify what reasons or causes might influence the changes in LD effectiveness, particularly if intestinal bacteria contribute to the breakdown of LD in patients with PD. This study is an observational cohort proof-of-concept study that follows PD patients who take PD at high-frequency doses and low-frequency doses. . Each PD patient will have a household healthy control/spouse enrolled into the study. Single patients with no spouse will still be eligible to enroll.

Conditions

  • Parkinson Disease

Interventions

DRUG

Low dose levodopa

Low frequency is defined as ≤ 3 LD doses a day

DRUG

High dose levodopa

High frequency dosage is defined as ≥ 5 LD doses per day

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-17
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04956939 on ClinicalTrials.gov