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A Pilot Study to Explore the Role of Gut Flora in Myasthenia Gravis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04224506
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

Study Description
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Brief Summary:
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Condition or disease Intervention/treatment
Myasthenia Gravis Myasthenia Gravis, Generalized Other: No intervention

Detailed Description:
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Myasthenia Gravis.
Study Design
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Study Type : Observational
Estimated 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 Myasthenia Gravis
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Myasthenia Gravis
Patients who have been diagnosed with Myasthenia Gravis.
 Other: No intervention
There is no intervention for this study.


Outcome Measures
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Primary Outcome Measures :
  1. Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing [ Time Frame: Three years ]
    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 with Myasthenia Gravis.


Biospecimen Retention:   Samples With DNA
Stool samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Myasthenia Gravis
Criteria

Inclusion Criteria:

  1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

    a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent

  2. Male or female of all ages.
  3. Diagnosis of Myasthenia Gravis by a physician

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04224506


Contacts
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Contact: Sabine Hazan, MD 18053390549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 18053390549 jordan@progenabiome.com

Locations
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United States, California
ProgenaBiome Recruiting
Ventura, California, United States, 93003
Contact: Sabine Hazan, MD    805-339-0549    drsabinehazan@progenabiome.com   
Contact: Jordan Daniels, MS    805-339-0549    jordan@progenabiome.com   
Principal Investigator: Sabine Hazan, MD         
Sponsors and Collaborators
ProgenaBiome
Investigators
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Study Director: Sabine Hazan ProgenaBiome
More Information
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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04224506    
Other Study ID Numbers: PRG-039
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
 Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases