Establishment of a Human Tissue Bank for Studying the Microbial Etiology of Neurodegenerative Diseases
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|ClinicalTrials.gov Identifier: NCT01954875|
Recruitment Status : Withdrawn (Study no longer funded)
First Posted : October 7, 2013
Last Update Posted : April 26, 2022
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.
|Condition or disease|
|Neurodegenerative Diseases Amyotrophic Lateral Sclerosis Multiple Sclerosis Parkinson Disease|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Establishment of a Human Tissue Bank for Studying the Microbial Etiology of Neurodegenerative Diseases|
|Actual Study Start Date :||December 2, 2009|
|Actual Primary Completion Date :||December 30, 2016|
|Actual Study Completion Date :||July 2, 2019|
Subjects with ALS
subjects diagnosed with amyotrophic lateral sclerosis
subjects with non-ALS neurodegenerative disease
subjects diagnosed with non-ALS neurodegenerative disease
healthy subjects as controls
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954875
|United States, North Carolina|
|Carolinas Medical Center - Dept of Neurology|
|Charlotte, North Carolina, United States, 28207|
|Principal Investigator:||Benjamin R Brooks, MD||Director, Neuromuscular ALS/MDA Center and Neuromuscular/ALS Research Laboratory|