Gastrointestinal DysmotilityNCT04880538
Enteric Neural Precursor Cells (ENPC) in the Human Gut
An observational study of Gastrointestinal Dysmotility, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Dysmotility
- What is being tested?
- Endoscopic procedure
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2021to 11 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with gastrointestinal diseases.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Enteric Neural Precursor Cells (ENPC) in the Human Gut - Identification of Molecular Signature and Characterization of Their Proliferative & Neurogenic Potential Using Surgical/Endoscopic Biopsies in Vitro
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.
Read the detailed description
(i) To study the structure and organization of the human Enteric Nervous System by tissue clarification, immunofluorescence, and 2-photon and light-sheet microscopy.
(ii) To find out the molecular signature that defines various gastrointestinal cells that include the neurons, glia, precursor cells within the Enteric Nervous System and cells associated with the Enteric Nervous System, such as Interstitial Cell of Cajal and macrophages in the human whole gut surgical resection and full thickness endoscopic resection-derived tissues using single cell RNA sequencing and analyses.
(iii) To isolate these cells and study their proliferative and neurogenic potential in vitro and on transplantation into the gut tissue of immunodeficient mice.
(iv) To time stamp and determine the age of Enteric Nervous System cells in adults and determine whether different enteric disease states alter the cycling times of these cells.
(v) To use gut specimens derived from surgical resections and full thickness endoscopic resection-derived tissues for
- Generating ex vivo preps to study and understand the electrophysiological properties of the gut wall and
- Generating cultured ex vivo preps to understand the interaction between enteric extracellular matrix and cells of the Enteric Nervous System.
- Conditions
- Gastrointestinal Dysmotility
- Being tested
- Endoscopic procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic procedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic patients for any motility disorder | Asymptomatic patients for any motility disorder Receives: Procedure: Endoscopic procedure | |
| Patients with gastrointestinal dysmotility | Patients with gastrointestinal dysmotility Receives: Procedure: Endoscopic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start26 Apr 2021
- Primary completion11 Sep 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysmotilityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ken Hui, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880538
- Sponsor's protocol ID
- IRB00146589
- Status last verified
- Mar 2024
- First submitted
- 30 Apr 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteric Neural Precursor Cells (ENPC) in the Human Gut - Identification of Molecular Signature and Characterization of Their Proliferative & Neurogenic Potential Using Surgical/Endoscopic Biopsies in Vitro
- ClinicalTrials.gov ID
- NCT04880538
- Acronym / sponsor ID
- IRB00146589
- Conditions
- Gastrointestinal Dysmotility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
(i) To study the structure and organization of the human Enteric Nervous System by tissue clarification, immunofluorescence, and 2-photon and light-sheet microscopy.
(ii) To find out the molecular signature that defines various gastrointestinal cells that include the neurons, glia, precursor cells within the Enteric Nervous System and cells associated with the Enteric Nervous System, such as Interstitial Cell of Cajal and macrophages in the human whole gut surgical resection and full thickness endoscopic resection-derived tissues using single cell RNA sequencing and analyses.
(iii) To isolate these cells and study their proliferative and neurogenic potential in vitro and on transplantation into the gut tissue of immunodeficient mice.
(iv) To time stamp and determine the age of Enteric Nervous System cells in adults and determine whether different enteric disease states alter the cycling times of these cells.
(v) To use gut specimens derived from surgical resections and full thickness endoscopic resection-derived tissues for
- Generating ex vivo preps to study and understand the electrophysiological properties of the gut wall and
- Generating cultured ex vivo preps to understand the interaction between enteric extracellular matrix and cells of the Enteric Nervous System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic patients for any motility disorder | – | Procedure: Endoscopic procedureAsymptomatic patients for any motility disorder |
| Patients with gastrointestinal dysmotility | – | Procedure: Endoscopic procedurePatients with gastrointestinal dysmotility |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gastrointestinal diseases.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic procedureEndoscopic 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. | Procedure or surgery | Asymptomatic patients for any motility disorder, Patients with gastrointestinal dysmotility |
Primary outcome
Visualization of the network of Nestin+ cells in human gut resection specimens.
Time frame: Up to one year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Hui, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Dysmotility, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization of the network of Nestin+ cells in human gut resection specimens. (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.