Status:
COMPLETED
A Study of Protein Metabolism, Microbiome and Investigational Probiotic Use in Patients With ALS
Lead Sponsor:
Avera McKennan Hospital & University Health Center
Conditions:
Amyotrophic Lateral Sclerosis
ALS
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 fr...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03324399
Start Date
June 1 2017
End Date
June 26 2019
Last Update
July 2 2019
Active Locations (1)
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1
Avera Medical Group Palliative Medicine Sioux Falls
Sioux Falls, South Dakota, United States, 57105