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

Completed · Not applicable

Conditions studied: Amyotrophic Lateral Sclerosis, ALS

In brief

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.

Key facts

Study ID

NCT03324399

Run by

Avera McKennan Hospital & University Health Center

People needed

5

Starts

2017-06-01

Expected to finish

2019-06-26

Last updated by the study team

2019-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of sporadic ALS, definite or probable disease,-revised El Escorial criteria
• Patient must be able to understand the purpose and procedures of the study, sign informed consent and comply with requirements of the protocol.
• Age 18 and older.
• Normal serum Magnesium (1.7 - 2.3 mg/dL) and Manganese (4.7 - 18.3 ng/mL) levels or adequate supplement to obtain normal serum Mg (if Manganese levels are low (<1.7 mg/dL), Hair Manganese will be evaluated before starting probiotic, and inclusion to the protocol will be at the principal investigators discretion).

You may not qualify if…

• Need for consumption of frequent antibiotics, gut pH increasing medications, and/or alkaline water.
• Patient unable to maintain regular follow up or submit to informed consent
• Stool pH >7.5 - The ideal stool pH for growth and function of the investigational probiotic is 6-6.5.
• Patients who are judged to be ineligible for study entry by investigator or sub-investigator.

Where it is running

• Avera Medical Group Palliative Medicine Sioux Falls — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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