A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Amyotrophic Lateral Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Correlation of Microbiome to ALS via Relative Abundance Found in Microbiome Sequencing
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Validation of Sequencing Methods(One year)