A Study to Explore the Role of Gut Flora in ALS

NCT04150809 | Withdrawn

• 1 other identifier: PRG-024
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ALS; Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Validation of Sequencing Methods

  One year

Study Arms (1)

Patients

Patients who have been diagnosed with ALS.

Other: No intervention

Interventions

No intervention OTHER

There is no intervention for this study

Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ALS

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ProgenaBiome: lead

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool Samples

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 5, 2019
• Study Start: March 2, 2020
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)