A Study to Explore the Role of Gut Flora in ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04150809
• Other study ID #: PRG-024
• Status: Recruiting
• Start date: March 2, 2020
• Est. completion date: July 2023

Study information

• Verified date: September 2021
• Source: ProgenaBiome
• Contact: Sabine Hazan, MD
• Phone: 18053390549
• Email: drsabinehazan[@]progenabiome.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• ALS
• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• No intervention
There is no intervention for this study

Locations

Country	Name	City	State
United States	ProgenaBiome	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
ProgenaBiome

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of Microbiome to ALS via Relative Abundance Found in Microbiome Sequencing	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.	One year
Secondary	Validation of Sequencing Methods	To validate the methods used to sequence sample	One year