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NCT03324399 · ClinicalTrials.gov registry record · NA

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

A NA study of Amyotrophic Lateral Sclerosis and ALS, sponsored by Avera McKennan Hospital & University Health Center.

Completed
Registry status
NA
Development phase
5
Enrollment target
1
Study location

NCT03324399: Completed NA study of Amyotrophic Lateral Sclerosis and ALS, sponsored by Avera McKennan Hospital & University Health Center.

NCT03324399 is a NA study of Amyotrophic Lateral Sclerosis and ALS that has completed, run by Avera McKennan Hospital & University Health Center. The registered enrollment target is 5 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03324399, a NA study of Amyotrophic Lateral Sclerosis and ALS, has completed, sponsored by Avera McKennan Hospital & University Health Center.

COMPLETED
Registry status
NA
Development phase
5 participants
Enrollment target
1
Study location

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.

Primary Outcome

Amino acid profiles will be compared before the probiotic use and over a period of treatment for 6 months.

Interventions

  • DIETARY_SUPPLEMENT probiotic

Study Locations (1)

South Dakota

  • Avera Medical Group Palliative Medicine Sioux Falls - Sioux Falls

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2017-06-01
Est. Completion 2019-06-26
Phase NA

What the finished NCT03324399 record still lists

NCT03324399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (99% lower).

The record links to 2 conditions, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which probiotic is the first listed.

NCT03324399 reports a single indexed study location in South Dakota.

Frequently Asked Questions

What is clinical trial NCT03324399 about?

NCT03324399 is a clinical study titled "A Study of Protein Metabolism, Microbiome and Investigational Probiotic Use in Patients With ALS". 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 A...

What is the current status of trial NCT03324399?

This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2017-06-01. Estimated completion is 2019-06-26.

What conditions does trial NCT03324399 study?

This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis, ALS.

What interventions are being tested in trial NCT03324399?

The interventions under investigation include: probiotic (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT03324399?

This trial is sponsored by Avera McKennan Hospital & University Health Center, which has 20 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03324399 being conducted?

This trial has 1 study location across South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Amyotrophic Lateral Sclerosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03324399's enrollment target sits among peer trials

5 94th of 102 higher than 7 of 102 other Amyotrophic Lateral Sclerosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03324399, the US trial registry maintained by the National Library of Medicine. NCT03324399 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.