Neurodegenerative DiseasesNCT01954875
Establishment of a Human Tissue Bank for Studying the Microbial Etiology of Neurodegenerative Diseases
An observational study of Neurodegenerative Diseases and Amyotrophic Lateral Sclerosis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The etiology of many neurodegenerative diseases is unknown. A few studies have suggested the role of infection in the gastrointestinal tract in the etiology and pathogenesis of neurological diseases such as idiopathic Parkinson. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases, Amyotrophic Lateral Sclerosis, Multiple Sclerosis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2009to 2 Jul 2019
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients at Carolinas Medical Center with and without neurodegenerative disease
Who may be able to join
- aged 18 years and older
- patients diagnosed with amyotrophic lateral sclerosis or other neurodegenerative disease, and healthy controls
Who cannot join
- Subjects with acute bacterial infection of the GI tract
- Subjects on treatments with antibiotics or probiotics within 28 days prior to sampling
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center - Dept of Neurology
Charlotte, North Carolina, 28207
About this study
The etiology of many neurodegenerative diseases is unknown. A few studies have suggested the role of infection in the gastrointestinal tract in the etiology and pathogenesis of neurological diseases such as idiopathic Parkinson. For example, infection with Helicobacter pylori has been suggested to play a role in Parkinson disease. In addition, bacterial pathogens such as spirochetes and bacterial products such as cyanobacterial toxins have been speculated as the contributing factors in the development of amyotrophic lateral sclerosis (ALS). The effect of microbial composition of the gut in the pathogenesis of ALS is suspected. The difference in the bacterial profile of the gut has been documented in diseases such as inflammatory bowel disease and obesity.
The goal of this IRB protocol is to create a human tissue bank and to obtain patients' demographic information for future investigation of the role of bacterial pathogens and the role of gut flora composition in the development of neurodegenerative diseases including but not limited to ALS, Parkinson's disease, and multiple sclerosis.
Read the detailed description
The purpose of this clinical trial is to create a bank of fecal and blood samples and associated coded demographic information for future investigation of the microbial etiology and pathophysiology of neurodegenerative diseases including but not limited to Amyotrophic Lateral Sclerosis (ALS), Parkinson's disease and multiple sclerosis.
Approximately 300 adult participants (open to all races and both sexes) subjects will be recruited (i.e. 100 healthy controls, 100 subjects with other neurodegenerative diseases (not ALS) and 100 subjects with ALS).
Inclusion criteria permit all adults aged >18 years of age with the diagnosis of ALS who are willing to provide informed consent and patients who do not have a diagnosis of ALS and are willing to provide informed consent. Subjects who do not provide informed consent, have acute bacterial infection of the GI tract, and/or are being treated with antibiotics or probiotics within 28 days prior to sampling are excluded. A separate blood sample will not be taken from a subject if the maximum amount of samples allowed have been collected for standard care.
Upon arrival to the clinic, staff will provide the stool tissue bank protocol informed consent / HIPAA authorization document to eligible subjects for review. If subjects indicate a willingness to participate, the research coordinator or one of the participating investigators will review the informed consent form / HIPAA authorization with the subjects and answer any questions. If subjects agree to participate, they will sign the informed consent form / HIPAA authorization. Copies of the document will be made for subjects; originals will be filed in a locked cabinet.
Biological materials will be collected from the patient using either one or both of the following methods: as biological samples obtained specifically for the study (e.g. stool samples from all participating patients) or as extra material obtained specifically for research in addition to material collected as part of routine care (e.g., blood samples).
Subjects will be asked to consider participating in the stool tissue bank protocol. If subjects consent to donate extra samples for the bank, the samples will be obtained by the physicians or the clinic staff.
Two 10 ml venous blood samples for the ALS tissue bank will be collected 1) in a serum separator, and 2) in a tube containing the anticoagulant, EDTA (lavender top). Stool samples will be collected in sterile plastic cups. The blood and stool samples will be put on ice or refrigerated as promptly as possible until delivered to the ALS Research Laboratory at Cannon Research Center.
Samples will be de-identified by labeling with a research code prior to entering the laboratory. All information pertaining to the sample including a copy of the consent form and the master list of the research coding will be secured in a locked file cabinet. Personal health information (PHI) obtained will be entered into a separate security-protected database utilizing encryption technology and accessible only to authorized personnel. The samples, once coded, will be given to the appropriate laboratory technician for processing and analysis.
Blood samples will be centrifuged, the plasma and serum samples will be aliquoted in 1 ml tubes and stored at -80 C. The blood cells, separated from plasma, will be processed for DNA isolation immediately or stored at -80 C for later DNA extraction. Four ~25 mg aliquots of stool samples will be stored in sterile tubes at -80 C for future analysis. Storage freezers are locked, connected to emergency power and monitored by an alarm system that notifies laboratory personnel of malfunctions, etc.
In addition, a data collection form will be completed by the research staff to collect demographic, medical history, etc. as shown in Appendix C. The form will be linked to the tissue samples by an individual research code. This information is necessary for defining the tissue samples collected.
No formal sample size determination will be performed for this tissue bank protocol.
- Conditions
- Neurodegenerative Diseases, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson Disease
- Keywords
- neurodegenerative diseases, amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's Disease
- Medical subject headings
- Neurodegenerative Diseases, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with ALS | subjects diagnosed with amyotrophic lateral sclerosis | |
| subjects with non-ALS neurodegenerative disease | subjects diagnosed with non-ALS neurodegenerative disease | |
| healthy controls | healthy subjects as controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a bank of fecal and blood samples to study the mirobial etiology of neurodegenerative diseases
The goal of this protocol is to create a human tissue bank of fecal and blood samples for the future investigation of the microbial etiology and pathophysiology of neurodegenerative diseases including but not limited to Amyotrophic Lateral Sclerosis, Parkinson's Disease, and Multiple Sclerosis. Patient demographic information will be collected to allow future study of the role of bacterial pathogens and gut flora composition in the development of neurodegenerative diseases.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study start2 Dec 2009
- Primary completion30 Dec 2016
- Study completion2 Jul 2019
Why it stopped: Study no longer funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin R Brooks, MD, Principal investigator, Director, Neuromuscular ALS/MDA Center and Neuromuscular/ALS Research Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954875
- Sponsor's protocol ID
- CHS-Neurology-ALS stool sample
- Status last verified
- Dec 2019
- First submitted
- 30 Mar 2013
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Human Tissue Bank for Studying the Microbial Etiology of Neurodegenerative Diseases
- ClinicalTrials.gov ID
- NCT01954875
- Acronym / sponsor ID
- CHS-Neurology-ALS stool sample
- Conditions
- Neurodegenerative Diseases, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson Disease
- Keywords
- neurodegenerative diseases, amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study no longer funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 2 Dec 2009 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 7 Oct 2013 (estimated)
- 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.
The etiology of many neurodegenerative diseases is unknown. A few studies have suggested the role of infection in the gastrointestinal tract in the etiology and pathogenesis of neurological diseases such as idiopathic Parkinson. For example, infection with Helicobacter pylori has been suggested to play a role in Parkinson disease. In addition, bacterial pathogens such as spirochetes and bacterial products such as cyanobacterial toxins have been speculated as the contributing factors in the development of amyotrophic lateral sclerosis (ALS). The effect of microbial composition of the gut in the pathogenesis of ALS is suspected. The difference in the bacterial profile of the gut has been documented in diseases such as inflammatory bowel disease and obesity.
The goal of this IRB protocol is to create a human tissue bank and to obtain patients' demographic information for future investigation of the role of bacterial pathogens and the role of gut flora composition in the development of neurodegenerative diseases including but not limited to ALS, Parkinson's disease, and multiple sclerosis.
Detailed description
The purpose of this clinical trial is to create a bank of fecal and blood samples and associated coded demographic information for future investigation of the microbial etiology and pathophysiology of neurodegenerative diseases including but not limited to Amyotrophic Lateral Sclerosis (ALS), Parkinson's disease and multiple sclerosis.
Approximately 300 adult participants (open to all races and both sexes) subjects will be recruited (i.e. 100 healthy controls, 100 subjects with other neurodegenerative diseases (not ALS) and 100 subjects with ALS).
Inclusion criteria permit all adults aged >18 years of age with the diagnosis of ALS who are willing to provide informed consent and patients who do not have a diagnosis of ALS and are willing to provide informed consent. Subjects who do not provide informed consent, have acute bacterial infection of the GI tract, and/or are being treated with antibiotics or probiotics within 28 days prior to sampling are excluded. A separate blood sample will not be taken from a subject if the maximum amount of samples allowed have been collected for standard care.
Upon arrival to the clinic, staff will provide the stool tissue bank protocol informed consent / HIPAA authorization document to eligible subjects for review. If subjects indicate a willingness to participate, the research coordinator or one of the participating investigators will review the informed consent form / HIPAA authorization with the subjects and answer any questions. If subjects agree to participate, they will sign the informed consent form / HIPAA authorization. Copies of the document will be made for subjects; originals will be filed in a locked cabinet.
Biological materials will be collected from the patient using either one or both of the following methods: as biological samples obtained specifically for the study (e.g. stool samples from all participating patients) or as extra material obtained specifically for research in addition to material collected as part of routine care (e.g., blood samples).
Subjects will be asked to consider participating in the stool tissue bank protocol. If subjects consent to donate extra samples for the bank, the samples will be obtained by the physicians or the clinic staff.
Two 10 ml venous blood samples for the ALS tissue bank will be collected 1) in a serum separator, and 2) in a tube containing the anticoagulant, EDTA (lavender top). Stool samples will be collected in sterile plastic cups. The blood and stool samples will be put on ice or refrigerated as promptly as possible until delivered to the ALS Research Laboratory at Cannon Research Center.
Samples will be de-identified by labeling with a research code prior to entering the laboratory. All information pertaining to the sample including a copy of the consent form and the master list of the research coding will be secured in a locked file cabinet. Personal health information (PHI) obtained will be entered into a separate security-protected database utilizing encryption technology and accessible only to authorized personnel. The samples, once coded, will be given to the appropriate laboratory technician for processing and analysis.
Blood samples will be centrifuged, the plasma and serum samples will be aliquoted in 1 ml tubes and stored at -80 C. The blood cells, separated from plasma, will be processed for DNA isolation immediately or stored at -80 C for later DNA extraction. Four ~25 mg aliquots of stool samples will be stored in sterile tubes at -80 C for future analysis. Storage freezers are locked, connected to emergency power and monitored by an alarm system that notifies laboratory personnel of malfunctions, etc.
In addition, a data collection form will be completed by the research staff to collect demographic, medical history, etc. as shown in Appendix C. The form will be linked to the tissue samples by an individual research code. This information is necessary for defining the tissue samples collected.
No formal sample size determination will be performed for this tissue bank protocol.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects with ALS | – | –subjects diagnosed with amyotrophic lateral sclerosis |
| subjects with non-ALS neurodegenerative disease | – | –subjects diagnosed with non-ALS neurodegenerative disease |
| healthy controls | – | –healthy subjects as controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Carolinas Medical Center with and without neurodegenerative disease
Key inclusion criteria (2 listed)
- aged 18 years and older
- patients diagnosed with amyotrophic lateral sclerosis or other neurodegenerative disease, and healthy controls
Key exclusion criteria (2 listed)
- Subjects with acute bacterial infection of the GI tract
- Subjects on treatments with antibiotics or probiotics within 28 days prior to sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Creation of a bank of fecal and blood samples to study the mirobial etiology of neurodegenerative diseases
Time frame: one year
The goal of this protocol is to create a human tissue bank of fecal and blood samples for the future investigation of the microbial etiology and pathophysiology of neurodegenerative diseases including but not limited to Amyotrophic Lateral Sclerosis, Parkinson's Disease, and Multiple Sclerosis. Patient demographic information will be collected to allow future study of the role of bacterial pathogens and gut flora composition in the development of neurodegenerative diseases.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
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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.
Benjamin R Brooks, MD principal investigator
Director, Neuromuscular ALS/MDA Center and Neuromuscular/ALS Research Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodegenerative Diseases and Amyotrophic Lateral Sclerosis, run by Wake Forest University Health Sciences 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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 26 Apr 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Creation of a bank of fecal and blood samples to study the mirobial etiology of neurodegenerative diseases (time frame: one year). 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 26 Apr 2022.