Skip to main content
OpenTrials
Completed

NCT Number: NCT03324399

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 Application for an investigational probiotic and have indicated the need for more study of this orphaned drug in ALS patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Avera Medical Group Palliative Medicine Sioux Falls

Sioux Falls, South Dakota, 57105, United States

About this study

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.

  • Purpose: Evaluate the clinical outcomes of muscle strength, clinical global assessments and spasticity in patients taking an Investigational probiotic.
  • Measure changes in questionnaires relating to subjective functional assessments, quality of life, and pain levels over 24 weeks.
  • Describe plasma amino acid levels before and after a protein food challenge in ALS patients of spinal and bulbar type.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement

a proprietary probiotic formulation

Primary outcomes

  1. Evaluate amino acid levels before and after probiotic use.

    Time frame: 6 months

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

Secondary outcomes

  1. Measure changes in questionnaires relating to subjective functional assessments.

    Time frame: 6 months

    Changes will be measured with Amyotrophic Lateral Sclerosis -Functional Rating Scale (ALS-FRS).

    The ALS-FRS is a 12 item questionnaire to assess bulbar, limb, and respiratory functions. The scores may range from 0, which is the worst function, to 48 which is the best function. This questionnaire is self-administered, and can be completed with assistance from a family member. The scores range from 0-48. The highest scores reflect no changes, or difficulty with tasks assessed. Low scores indicate poor functioning and need for assistance.

  2. Measure changes in Quality of Life.

    Time frame: 6 months

    Changes will be measured with the Amyotrophic Lateral Sclerosis -Quality of Life questionnaire. The ALS-QOL is a 50-item, self-administered, questionnaire which includes 7 scores. These scores represent six domains and a total average score. The six domains are 1) Negative Emotion, 2) Interaction, 3) Intimacy, 4) Religiosity, 5) Physical and 6) Bulbar.

  3. Evaluate pain levels with the Numbered Pain Scale.

    Time frame: 6 months

    Changes in pain rating of 0 - 10 will be collected during the 6 months of study.

Sponsors and collaborators

Lead sponsor

Avera McKennan Hospital & University Health Center

Other

Registry information

Official study title

A Study of Protein Metabolism, Microbiome and Investigational Probiotic Use in Patients With Amyotrophic Lateral Sclerosis (ALS)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 27, 2017
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.