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

NCT03324399 | Completed

• 1 other identifier: AIHG-2017.004-ALS
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 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

Amyotrophic Lateral Sclerosis; ALS

Keywords

ALS; Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Evaluate amino acid levels before and after probiotic use.

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

  6 months

Secondary Outcomes (3)

• Measure changes in questionnaires relating to subjective functional assessments.

  6 months

• Measure changes in Quality of Life.

  6 months

• Evaluate pain levels with the Numbered Pain Scale.

  6 months

Study Arms (2)

High Amino Acid levels

EXPERIMENTAL

Comparison between high amino acid levels and low amino acid levels of clinical global assessments, muscle strength and spasticity and functional assessments. Patients taking proprietary probiotic

Dietary Supplement: probiotic

Low Amino Acid levels

EXPERIMENTAL

Comparison between high amino acid levels and low amino acid levels of clinical global assessments, muscle strength and spasticity and functional assessments. Patients taking proprietary probiotic

Dietary Supplement: probiotic

Interventions

probiotic DIETARY_SUPPLEMENT

a proprietary probiotic formulation

High Amino Acid levels; Low Amino Acid levels

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Avera McKennan Hospital & University Health Center: lead

Study Sites (1)

Avera Medical Group Palliative Medicine Sioux Falls

Sioux Falls, South Dakota, 57105, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Francine Arneson, MD

  Avera Medical Group Palliative Medicine Sioux Falls

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: October 27, 2017
• Study Start: June 1, 2017
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: July 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)