A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Amyotrophic Lateral Sclerosis

Study Purpose:

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding ALS.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Observational Study

Study Category:

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Sabine Hazan, MD, ProgenaBiome

Clinicaltrials.gov ID (11 digit #):

NCT04150809

Neals Affiliated?

No

Coordinating Center Contact Information

ProgenaBiome
Sabine Hazan, MD / .(JavaScript must be enabled to view this email address) / 805-339-0549
Jordan Daniels, MS / .(JavaScript must be enabled to view this email address) / 805-339-0549
Ventura, California 93003 United States

Full Study Summary:

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 ALS.

Study Sponsor:

ProgenaBiome

Participant Duration:

Estimated Enrollment:

100

Estimated Study Start Date:

03/02/2020

Estimated Study Completion Date:

07/31/2023

Posting Last Modified Date:

04/02/2020

Date Study Added to alsconsortium.org:

04/02/2020
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    N/A

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    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 ALS

    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

  • Site Contact Information

    ProgenaBiome
    Sabine Hazan, MD / .(JavaScript must be enabled to view this email address) / 805-339-0549
    Jordan Daniels, MS / .(JavaScript must be enabled to view this email address) / 805-339-0549
    Ventura, California 93003
    United States