Study Purpose:
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding ALSStudy Status:
Recruiting
Disease:
ALS , Amyotrophic Lateral Sclerosis , Motor Neuron Disease
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Sabine Hazan, MD, ProgenaBiome
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
ProgenaBiome
Sabine Hazan, MD / email hidden; JavaScript is required / 18053390549
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
Estimated Enrollment:
100
Estimated Study Start Date:
03 / 02 / 2020
Estimated Study Completion Date:
07 / 01 / 2023
Posting Last Modified Date:
09 / 05 / 2021
Date Study Added to neals.org:
11 / 05 / 2019
Minimum Age:
N/A
Maximum Age:
N/A
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
ProgenaBiome | Recruiting
Sabine Hazan, MD / 805-339-0549 / email hidden; JavaScript is required
Jordan Daniels, MS / 18053390549 / email hidden; JavaScript is required
Principal Investigator : Sabine Hazan, MD
Ventura, California
93003
United States