A Study of Protein Metabolism, Microbiome and Investigational Probiotic Use in Patients With ALS

NCT03324399 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-07-02

No results posted yet for this study

Summary

ALS, also known as "Lou Gehrig's" disease, is a neurodegenerative disease which is fatal. Treatment for ALS is limited and currently consists of primary symptom relief or support. In addition, time from diagnosis to death averages 3-5 years. New Biotic, LLC has submitted an Orphan Drug Designation Application for an investigational probiotic and have indicated the need for more study of this orphaned drug in ALS patients.

Conditions

Interventions

DIETARY_SUPPLEMENT

probiotic

a proprietary probiotic formulation

Sponsors & Collaborators

  • Avera McKennan Hospital & University Health Center

    lead OTHER

Principal Investigators

  • Francine Arneson, MD · Avera Medical Group Palliative Medicine Sioux Falls

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2019-06-26
Completion
2019-06-26

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03324399 on ClinicalTrials.gov