GastroparesisNCT04894656
Intestinal Permeability and Gastroparesis
A study testing Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy in people with Gastroparesis and Healthy, run by Mayo Clinic.
Trial summary
The purpose of this study is to investigate potential mechanisms that could lead to the development of a condition known as gastroparesis. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis, Healthy
- What is being tested?
- Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to Jul 2023
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (18-75 years old).
- Men and women.
- Patients with gastroparesis.
Who cannot join
- Patients will be excluded from the study if symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), GERD, esophagitis, eosinophilic esophagitis or H. pylori.
- Patients with uncontrolled diabetes mellitus (hemoglobin A1C > 10).
- Patients with prior surgery to the esophagus, stomach or duodenum.
- Patients taking opioids, steroids, anti-histamines, immunosuppressive agents, NSAIDs, or mast cell stabilizing agents within the prior 3 months.
- Patients currently prescribed aspirin or aspirin regimens for other clinical reasons.
- Patients with known allergies to lactulose: mannitol will be excluded.
About this study
Official title: Assessing Intestinal Barrier Function and Permeability in Patients With Gastroparesis
The purpose of this study is to investigate potential mechanisms that could lead to the development of a condition known as gastroparesis.
- Conditions
- Gastroparesis, Healthy
- Being tested
- Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopyDiagnostic test
Tests to assess intestinal permeability
| Study group | Role | What they receive |
|---|---|---|
| Gastroparesis patients | Experimental | Not described Receives: Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy |
| Healthy volunteers | Active comparator | Not described Receives: Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy.
Measured: through study completion, approximately 3-4 days
Secondary outcomes (4)
Assess small intestinal permeability using the lactulose:mannitol urinary excretion test.
Measured: through study completion, approximately 3-4 days
Measure serum levels of immune markers (e.g., IL-1,4,6,10,12,13,18; zonulin, CRP, TNF-alpha, tryptase,) in GP patients and compare to healthy controls.
Measured: One time measurement
Quantitate different duodenal cell types (e.g., mast cells (CK117), eosinophils, enterochromaffin, intraepithelial lymphocytes (IELs) and CCK-containing cells) in patients with GP using biopsies from both the D1 and D2 duodenal segments.
Measured: through study completion, approximately 3-4 days
Assess the relationship of GP symptoms to intestinal permeability, using validated questionnaires, and to histopathological changes.
Measured: through study completion, approximately 3-4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Apr 2022
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: Study withdrawn due to funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David J. Cangemi, Mayo Clinic
- Investigators
- David Cangemi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894656
- Sponsor's protocol ID
- 21-000771
- Status last verified
- Apr 2023
- First submitted
- 11 May 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Intestinal Barrier Function and Permeability in Patients With Gastroparesis
- ClinicalTrials.gov ID
- NCT04894656
- Acronym / sponsor ID
- 21-000771
- Conditions
- Gastroparesis, Healthy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 20 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 purpose of this study is to investigate potential mechanisms that could lead to the development of a condition known as gastroparesis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastroparesis patients | Experimental | Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy |
| Healthy volunteers | Active comparator | Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (18-75 years old).
- Men and women.
- Patients with gastroparesis.
Key exclusion criteria (6 listed)
- Patients will be excluded from the study if symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), GERD, esophagitis, eosinophilic esophagitis or H. pylori.
- Patients with uncontrolled diabetes mellitus (hemoglobin A1C > 10).
- Patients with prior surgery to the esophagus, stomach or duodenum.
- Patients taking opioids, steroids, anti-histamines, immunosuppressive agents, NSAIDs, or mast cell stabilizing agents within the prior 3 months.
- Patients currently prescribed aspirin or aspirin regimens for other clinical reasons.
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 |
|---|---|---|
| Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopyTests to assess intestinal permeability | Diagnostic test | Gastroparesis patients, Healthy volunteers |
Primary outcome
Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy.
Time frame: through study completion, approximately 3-4 days
4 secondary outcomes
Assess small intestinal permeability using the lactulose:mannitol urinary excretion test.
Time frame: through study completion, approximately 3-4 days
Measure serum levels of immune markers (e.g., IL-1,4,6,10,12,13,18; zonulin, CRP, TNF-alpha, tryptase,) in GP patients and compare to healthy controls.
Time frame: One time measurement
Quantitate different duodenal cell types (e.g., mast cells (CK117), eosinophils, enterochromaffin, intraepithelial lymphocytes (IELs) and CCK-containing cells) in patients with GP using biopsies from both the D1 and D2 duodenal segments.
Time frame: through study completion, approximately 3-4 days
Assess the relationship of GP symptoms to intestinal permeability, using validated questionnaires, and to histopathological changes.
Time frame: through study completion, approximately 3-4 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
David Cangemi, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy in people with Gastroparesis and Healthy, run by Mayo Clinic.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy. (time frame: through study completion, approximately 3-4 days). 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 19 Apr 2023.