Amyotrophic Lateral SclerosisNCT03324399
A Study of Protein Metabolism, Microbiome and Investigational Probiotic Use in Patients With ALS
A study testing probiotic in people with Amyotrophic Lateral Sclerosis and ALS, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, ALS
- What is being tested?
- probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 26 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera Medical Group Palliative Medicine Sioux Falls
Sioux Falls, South Dakota, 57105
About this study
Official title: 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.
Read the 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 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.
- Conditions
- Amyotrophic Lateral Sclerosis, ALS
- Being tested
- probiotic
- Keywords
- ALS, Amyotrophic Lateral Sclerosis
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticDietary supplement
a proprietary probiotic formulation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Measure changes in questionnaires relating to subjective functional assessments.
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.
Measured: 6 months
Measure changes in Quality of Life.
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.
Measured: 6 months
Evaluate pain levels with the Numbered Pain Scale.
Changes in pain rating of 0 - 10 will be collected during the 6 months of study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Jun 2017
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francine Arneson, MD, Principal investigator, Avera Medical Group Palliative Medicine Sioux Falls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324399
- Sponsor's protocol ID
- AIHG-2017.004-ALS
- Status last verified
- Jul 2019
- First submitted
- 5 Sep 2017
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Protein Metabolism, Microbiome and Investigational Probiotic Use in Patients With Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT03324399
- Acronym / sponsor ID
- AIHG-2017.004-ALS
- Conditions
- Amyotrophic Lateral Sclerosis, ALS
- Keywords
- ALS, Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Amino Acid levels | Experimental | Dietary Supplement: probioticComparison 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 |
| Low Amino Acid levels | Experimental | Dietary Supplement: probioticComparison 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotica proprietary probiotic formulation | Dietary supplement | High Amino Acid levels, Low Amino Acid levels |
Primary outcome
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.
3 secondary outcomes
Measure changes in questionnaires relating to subjective functional assessments.
Time frame: 6 months
Measure changes in Quality of Life.
Time frame: 6 months
Evaluate pain levels with the Numbered Pain Scale.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francine Arneson, MD principal investigator
Avera Medical Group Palliative Medicine Sioux Falls
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic in people with Amyotrophic Lateral Sclerosis and ALS, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate amino acid levels before and after probiotic use. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.