A Study to Explore the Role of Gut Flora in ALS

NCT ID: NCT04150809

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-02

Study Completion Date

2030-07-31

Brief Summary

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

Detailed Description

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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

Conditions

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ALS Amyotrophic Lateral Sclerosis Motor Neuron Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients who have been diagnosed with ALS.

No intervention

Intervention Type OTHER

There is no intervention for this study

Interventions

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No intervention

There is no intervention for this study

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ProgenaBiome

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabine Hazan, MD

Role: PRINCIPAL_INVESTIGATOR

ProgenaBiome

Locations

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ProgenaBiome

Ventura, California, United States

Site Status

Countries

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United States

Other Identifiers

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PRG-024

Identifier Type: -

Identifier Source: org_study_id

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