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



Status:Active, not recruiting
Conditions:Neurology, Neurology, Neurology, ALS
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:6/28/2018
Start Date:June 1, 2017
End Date:July 2019

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A Study of Protein Metabolism, Microbiome and Investigational Probiotic Use in Patients With Amyotrophic Lateral Sclerosis (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 Application for an investigational probiotic and have indicated the
need for more study of this orphaned drug in ALS patients.

This will be an exploratory protocol of 10 patients and expect to screen approximately 25-30
patients.

The purpose of our study is to examine amino acid levels in plasma pre and post prandial as
well as longitudinal gut microbiome in ALS patients taking the investigational probiotic.

1. Purpose: Evaluate the clinical outcomes of muscle strength, clinical global assessments
and spasticity in patients taking an Investigational probiotic.

2. Measure changes in questionnaires relating to subjective functional assessments, quality
of life, and pain levels over 24 weeks.

3. Describe plasma amino acid levels before and after a protein food challenge in ALS
patients of spinal and bulbar type.

4. Evaluate and describe the gut microbiome of patients with ALS.

Design:

This is a non-randomized, open-label, two-group pilot study of plasma amino acid levels, gut
microbiome, and of investigational probiotic use in patients with ALS. Participants will be
placed into two groups based on certain post-prandial amino acid levels. Patients will be
stratified for eligibility based on the results of their amino acid profiles.

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.
We found this trial at
1
site
1301 South Cliff Avenue
Sioux Falls, South Dakota 57105
?
mi
from
Sioux Falls, SD
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