Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT01954875 |
| Other study ID # |
CHS-Neurology-ALS stool sample |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2, 2009 |
| Est. completion date |
July 2, 2019 |
Study information
| Verified date |
December 2019 |
| Source |
Wake Forest University Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
