Enteric Neural Precursor Cells (ENPC) in the Human Gut

NCT04880538 | Completed

• 1 other identifier: IRB00146589
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The study aim is to acquire human tissues to (a) understand the structure and organization of the human Enteric Nervous System; (b) perform a molecular transcriptomic profile of individual cells residing in the human gut; (c) study the turnover rates of individual cell types by Fluorescence-activated cell sorting-aided C14 dating of cells; and finally (d) culture the human gut-derived cells characterize the human adult enteric neural stem cell and study its potential for Neuro-glial differentiation. This study will advance our knowledge of the the cellular and molecular correlates of changes in the Enteric Nervous System that are associated with disorders of motility.

Conditions

Gastrointestinal Dysmotility

Outcome Measures

Primary Outcomes (1)

• Visualization of the network of Nestin+ cells in human gut resection specimens.

  Presence or absence of antibodies (including but not limited to) specific to Nestin, p75 neurotrophin receptor, pan-neuronal antibodies, pan-glial antibodies, antibodies against Interstitial Cells of Cajal.

  Up to one year

Study Arms (2)

Asymptomatic patients for any motility disorder

Asymptomatic patients for any motility disorder

Procedure: Endoscopic procedure

Patients with gastrointestinal dysmotility

Patients with gastrointestinal dysmotility

Procedure: Endoscopic procedure

Interventions

Endoscopic procedure PROCEDURE

Endoscopic biopsy of one or more of the following: esophagus, stomach, small bowel, colon, or rectum as part of patient clinical care. Biopsies will be performed during endoscopy or colonoscopy and will be transported to the research laboratory for evaluation.

Asymptomatic patients for any motility disorder; Patients with gastrointestinal dysmotility

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with gastrointestinal diseases.

You may qualify if:

• English speaking patients in the age range 18 - 100.
• Patients suffering from Irritable Bowel Syndrome, Inflammatory Bowel Disease, Diabetes, Gastroparesis, will be included.
• Patients suffering from Collagen disorders such as Alport Syndrome, Ehlers-Danlos Syndrome, Goodpasture Syndrome.
• Patients suffering from plexiform neurofibromas.
• Patients with bariatric surgery.
• Patients with appendicitis.
• Patients with scleroderma.

You may not qualify if:

• Patients suffering from HIV, Hepatitis C, and other infectious diseases that require the handling of tissues in a Bio-safety level 3 environment.
• Patients suffering from infectious enteric disorders.
• Patients without any Gastrointestinal disorders (i.e. healthy volunteers).

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endoscopic GI tract biopsies

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ken Hui, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 10, 2021
• Study Start: April 26, 2021
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

US (1)