A Pilot Study to Explore the Role of Gut Flora in Parkinson's Disease

Sponsor
ProgenaBiome (Other)
Overall Status
Recruiting
CT.gov ID
NCT04148326
Collaborator
(none)
100
1
40
2.5

Study Details

Study Description

Brief Summary

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Parkinson's Disease.

Detailed Description

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Parkinson's Disease.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Parkinson's Disease
Actual Study Start Date :
Mar 2, 2020
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients

Patients who have been diagnosed with Parkinson's Disease

Other: No Intervention
There is no intervention for this study.

Outcome Measures

Primary Outcome Measures

  1. Correlation of Microbiome to Parkinson's Disease via Relative Abundance Found in Microbiome Sequencing [One Year]

    Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific disease types

Secondary Outcome Measures

  1. Validation of Sequencing Methods [One year]

    To validate the methods used to sequence samples

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

  2. Male or female patients of any age (interest is given to children to compare with mothers).

  3. Diagnosis of Parkinson's Disease

Exclusion Criteria:
  1. Refusal to sign informed consent form

  2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.

  3. Postoperative stoma, ostomy, or ileoanal pouch

  4. Participation in any experimental drug protocol within the past 12 weeks

  5. Treatment with total parenteral nutrition

  6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial

  7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Contacts and Locations

Locations

Site City State Country Postal Code
1 ProgenaBiome Ventura California United States 93003

Sponsors and Collaborators

  • ProgenaBiome

Investigators

  • Principal Investigator: Sabine Hazan, MD, ProgenaBiome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ProgenaBiome
ClinicalTrials.gov Identifier:
NCT04148326
Other Study ID Numbers:
  • PRG-021
First Posted:
Nov 1, 2019
Last Update Posted:
Sep 5, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021