A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Amyotrophic Lateral Sclerosis
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 Chair(s)/Principal Investigator(s):
Sabine Hazan, MD, ProgenaBiome
Clinicaltrials.gov ID (11 digit #):NCT04150809
Coordinating Center Contact InformationProgenaBiome
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.
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
Time since Symptom Onset:
Time since Diagnosis:
Can participants use Riluzole?Yes
- Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
- Male or female patients of any age (interest is given to children to compare with mothers).
- Diagnosis of ALS
- Refusal to sign informed consent form
- History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
- Postoperative stoma, ostomy, or ileoanal pouch
- Participation in any experimental drug protocol within the past 12 weeks
- Treatment with total parenteral nutrition
- Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
- Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
- Site Contact Information