A Study to Explore the Role of Gut Flora in ALS

June 2, 2025 updated by: ProgenaBiome

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • ProgenaBiome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with ALS

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients who have been diagnosed with ALS.
Other: No intervention
There is no intervention for this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of Sequencing Methods
Time Frame: One year
To validate the methods used to sequence sample
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProgenaBiome

Investigators

  • Principal Investigator: Sabine Hazan, MD, ProgenaBiome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2020

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

June 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRG-024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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