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A Study to Explore the Role of Gut Flora in ALS

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: NCT04150809
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

Tracking Information
First Submitted Date October 30, 2019
First Posted Date November 5, 2019
Last Update Posted Date September 5, 2021
Actual Study Start Date March 2, 2020
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 31, 2019)		 Correlation of Microbiome to ALS via Relative Abundance Found in Microbiome Sequencing [ Time Frame: One year ]
The identification of bacterial species residing the gut flora will be processed by next generation sequencing followed by metagenomic analysis. Bacterial diversity will then be evaluated in parallel with relative abundance of targeted species within and among individual microbes. In other words, in patients with ALS a specific microbe or class of microbes might represent a larger percentage of the microbiome when compared to healthy individuals. There could also be a higher or lower Shannon Index.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 31, 2019)		 Validation of Sequencing Methods [ Time Frame: One year ]
To validate the methods used to sequence sample
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study to Explore the Role of Gut Flora in ALS
Official Title A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Amyotrophic Lateral Sclerosis
Brief Summary This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding ALS
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 ALS
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Stool Samples
Sampling Method Non-Probability Sample
Study Population Patients with ALS
Condition
  • ALS
  • Amyotrophic Lateral Sclerosis
  • Motor Neuron Disease
Intervention Other: No intervention
There is no intervention for this study
Study Groups/Cohorts Patients
Patients who have been diagnosed with ALS.
Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 31, 2019)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Sabine Hazan, MD 18053390549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 18053390549 jordan@progenabiome.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04150809
Other Study ID Numbers PRG-024
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: There is no plan to share IPD
Current Responsible Party ProgenaBiome
Original Responsible Party Same as current
Current Study Sponsor ProgenaBiome
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Sabine Hazan, MD ProgenaBiome
PRS Account ProgenaBiome
Verification Date September 2021