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Novel Antineuronal Antibodies in Gastrointestinal Motility Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04872439
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief Summary:
Gastrointestinal motility disorders represent a heterogeneous group of neuromuscular diseases of the enteric nervous systems. While autoimmune neuromuscular diseases of the central nervous system (CNS) are well described, the role of autoimmunity in enteric nervous system (ENS) has been less studied. Approximately 10% of patients with unexplained gastrointestinal dysmotility diseases have positive serum autoantibodies to peripheral nervous system proteins, suggesting an autoimmune mechanism targeting the enteric nervous system. The investigator's aim is to identify novel anti neuronal antibodies that contribute to autoimmune gastrointestinal motility disorders by analyzing the serum of patients with abnormal gastrointestinal motility.

Condition or disease Intervention/treatment
Autoimmune Gastrointestinal Dysmotility Diagnostic Test: Blood sample collection

Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Antineuronal Antibodies in Gastrointestinal Motility Disorders
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Antibody isolation Diagnostic Test: Blood sample collection
Patients with autoimmune gastrointestinal dysmotility will provide 20 mL of blood to isolate serum, plasma and peripheral blood mononuclear cells for whole exome sequence. Antibodies to be isolated are: Antineuronal nuclear antibody type 1,Collapsing response-mediator family immunoglobulin G, Ganglionic Acetylcholine Receptor Antibody, Muscle Acetylcholine Receptor Antibody, Striational, Voltage-gated calcium channel, N- type, Voltage-gated calcium channel, P/Q- type, Voltage-gated potassium channel, Glutamic Acid Decarboxylase 65, Gastric parietal cell, Thyroperoxidase, Thyroglobulin


Outcome Measures
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Primary Outcome Measures :
  1. Antibodies for Autoimmune Gastrointestinal Dysmotility [ Time Frame: Baseline ]
    Presence or absence of Autoimmune Gastrointestinal Dysmotility specific antibodies.


Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with autoimmune gastrointestinal dysmotolity
Criteria

Inclusion Criteria:

  • Males and females >13 years old.
  • Patient referred to the GI Motility clinic for suspected enteric dysmotility based on chronic refractory gastrointestinal symptoms
  • English proficiency and literacy sufficient to sign consent.

Exclusion Criteria:

  • Pregnancy documented with a serum or urine pregnancy test. If participants believe that they are pregnant, they will need to notify a study physician who will order a serum or urine test for pregnancy and remove them from the study if the test results come back positive.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04872439


Contacts
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Contact: Pankaj J Pasricha, MD 410-550-1793 pasricha@jhu.edu
Contact: Guillermo A Barahona, MD 410-603-8343 gbaraho1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Pankaj Pasricha, MD    410-550-1793    pasricha@jhu.edu   
Contact: Guillermo Barahona, MD    4106038343    gbaraho1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Pankaj J Pasricha, MD Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04872439    
Other Study ID Numbers: IRB00114555
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No