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Establishment of a Human Tissue Bank for Studying the Microbial Etiology of Neurodegenerative Diseases

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Carolinas Healthcare System
Sponsor:
Information provided by (Responsible Party):
Benjamin Brooks, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01954875
First received: March 30, 2013
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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
Neurodegenerative Diseases
Amyotrophic Lateral Sclerosis
Multiple Sclerosis
Parkinson Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Establishment of a Human Tissue Bank for Studying the Microbial Etiology of Neurodegenerative Diseases

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Create a 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 Diseases, and multiple sclerosis. [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood, feces


Estimated Enrollment: 300
Study Start Date: December 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects with ALS
subjects diagnosed with amyotrophic lateral sclerosis
subjects with non-ALS neurodegenerative disease
subjects diagnosed with non-ALS neurodegenerative disease
healthy controls

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients at Carolinas Medical Center with and without neurodegenerative disease

Criteria

Inclusion Criteria:

  • aged 18 years and older
  • patients diagnosed with amyotrophic lateral sclerosis or other neurodegenerative disease, and healthy controls

Exclusion Criteria:

  • Subjects with acute bacterial infection of the GI tract
  • Subjects on treatments with antibiotics or probiotics within 28 days prior to sampling
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954875

Contacts
Contact: Carissa Tonkins 704-446-0836 carissa.tonkins@carolinashealthcare.org
Contact: Cynthia Lary 704-446-6063 cynthia.lary@carolinashealthcare.org

Locations
United States, North Carolina
Carolinas Medical Center - Dept of Neurology Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Carissa Tonkins    704-446-0836    carissa.tonkins@carolinashealthcare.org   
Contact: Cynthia Lary    704-446-6063    cynthia.lary@carolinashealthcare.org   
Sponsors and Collaborators
Benjamin Brooks
Investigators
Principal Investigator: Benjamin R Brooks, MD Director, Neuromuscular ALS/MDA Center and Neuromuscular/ALS Research Laboratory
  More Information

No publications provided

Responsible Party: Benjamin Brooks, Director, Neuromuscular ALS/MDA Center and Neuromuscular/ALS Research Laboratory, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01954875     History of Changes
Other Study ID Numbers: CHS-Neurology-ALS stool sample
Study First Received: March 30, 2013
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
neurodegenerative diseases
amyotrophic lateral sclerosis
multiple sclerosis
Parkinson's Disease

Additional relevant MeSH terms:
Neurodegenerative Diseases
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Multiple Sclerosis
Parkinson Disease
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Metabolic Diseases
Movement Disorders
Nervous System Diseases
Neuromuscular Diseases
Parkinsonian Disorders
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on October 30, 2014