Eosinophilic EsophagitisNCT04506593
Indiana University Gastrointestinal Motility Diagnosis Registry
An observational study of Eosinophilic Esophagitis and Gastroesophageal Reflux Disease (GERD), run by Indiana University at 1 site in United States.
Trial summary
Develop a registry (list of patients) with accurate clinical motility diagnosis. This registry will help the doctors to identify the patients with specific disease conditions. It will also help in promoting future research in gastroenterology motility disorders Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eosinophilic Esophagitis, Gastroesophageal Reflux Disease (GERD), Gastroparesis
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2014to Nov 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All Patients who presented to the GI outpatient clinics, in-patient consult service, and outpatient endoscopy centers within the Division of Gastroenterology and Hepatology
Who may be able to join
- Patients who presented to the GI outpatient clinics, in-patient consult service, and outpatient endoscopy centers within the Division of Gastroenterology and Hepatology
- Carries a diagnosis of GI motility disorder based on the diagnostic criteria listed in table
Who cannot join
- 1. Coexisting medical conditions that may limiting participation in clinical research trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maureen Schilling contact
United States1 site, 1 recruiting
- Recruiting
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
Maureen Schilling, BA, 317-278-2064, maschi@iu.edu
Thomas V Nowak, MD
About this study
Official title: Gastrointestinal Motility Diagnosis Registry
Develop a registry (list of patients) with accurate clinical motility diagnosis. This registry will help the doctors to identify the patients with specific disease conditions. It will also help in promoting future research in gastroenterology motility disorders
Read the detailed description
Develop a registry (list of patients) of patients seen the clinics with motility disorders. Motility diagnosis based on billing diagnostic codes are not accurate. Motility diagnosis will be made by physicians with specialized in GI Motility, based on clinical consensus of diagnostic criteria. The information gathered from the database will be used to help promote future clinical research in the GI motility and Neurogastroenterology Unit at Indiana University School of Medicine.
Gastrointestinal motility symptoms are very common. It encompasses a wide range of problems, such as dysphagia, heartburn, nausea, emesis, food regurgitation, abdominal distension, weight loss, postprandial bloating, constipation, and diarrhea. An accurate diagnosis is essential in order to promote cost-effective treatment and future research to benefit patients with GI motility disorders
Specific Aims
- Primary Aim: Identification of patients by accurate motility diagnosis
- Secondary Aims:
- To develop Patient Reported Outcome (PRO) measurements in patients with small intestinal bacterial overgrowth (SIBO)
- To develop Patient Reported Outcome (PRO) measurements in patients with gastroparesis
- Conditions
- Eosinophilic Esophagitis, Gastroesophageal Reflux Disease (GERD), Gastroparesis, Functional Vomiting, Irritable Bowel Syndrome (IBS), Constipation
- Being tested
- no intervention
- Keywords
- Eosinophilic esophagitis, Chronic intestinal pseudo-obstruction, Small Bowel dysmotility, SIBO, Vomiting, Functional dyspepsia, Functional bloating, Gastroparesis
- Medical subject headings
- Eosinophilic Esophagitis, Gastroesophageal Reflux, Gastroparesis, Irritable Bowel Syndrome, Constipation, Fecal Incontinence, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of patients by accurate motility diagnosis
Motility diagnosis will be made by physicians with specialized in GI Motility, based on consensus diagnostic criteria. The information gathered from the database will be used to help promote future clinical development and research in GI motility disorders.
Measured: .through study completion, an average of 10 years
Secondary outcomes (2)
Patient Reported Outcome (PRO) Measurements in Patients with Small Intestinal Bacterial Overgrowth (SIBO)
SIBO-disease specific patient questionnaire will be compared between patients with aerodigestive tract SIBO and coliform SIBO
Measured: through study completion, an average of 10 years
Patient Reported Outcome (PRO) Measurements in Patients with Gastroparesis
Patient Assessment of GI - Symptom (PAGI-SYM) scores will be compared between patients with emesis-predominant, dyspeptic-predominant, and regurgitation-predominant gastroparesis.
Measured: through study completion, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Nov 2014
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Indiana 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
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John M. Wo, Indiana University
- Investigators
- John m Wo, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506593
- Sponsor's protocol ID
- GI Database
- Other IDs
- 1403899260
- Status last verified
- Aug 2025
- First submitted
- 16 Jul 2016
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: observational registry
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Motility Diagnosis Registry
- ClinicalTrials.gov ID
- NCT04506593
- Acronym / sponsor ID
- GI Database
- Conditions
- Eosinophilic Esophagitis, Gastroesophageal Reflux Disease (GERD), Gastroparesis, Functional Vomiting, Irritable Bowel Syndrome (IBS), Constipation
- Keywords
- Eosinophilic esophagitis, Chronic intestinal pseudo-obstruction, Small Bowel dysmotility, SIBO, Vomiting, Functional dyspepsia, Functional bloating, Gastroparesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Aug 2020 (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.
Develop a registry (list of patients) with accurate clinical motility diagnosis. This registry will help the doctors to identify the patients with specific disease conditions. It will also help in promoting future research in gastroenterology motility disorders
Detailed description
Develop a registry (list of patients) of patients seen the clinics with motility disorders. Motility diagnosis based on billing diagnostic codes are not accurate. Motility diagnosis will be made by physicians with specialized in GI Motility, based on clinical consensus of diagnostic criteria. The information gathered from the database will be used to help promote future clinical research in the GI motility and Neurogastroenterology Unit at Indiana University School of Medicine.
Gastrointestinal motility symptoms are very common. It encompasses a wide range of problems, such as dysphagia, heartburn, nausea, emesis, food regurgitation, abdominal distension, weight loss, postprandial bloating, constipation, and diarrhea. An accurate diagnosis is essential in order to promote cost-effective treatment and future research to benefit patients with GI motility disorders
Specific Aims
- Primary Aim: Identification of patients by accurate motility diagnosis
- Secondary Aims:
- To develop Patient Reported Outcome (PRO) measurements in patients with small intestinal bacterial overgrowth (SIBO)
- To develop Patient Reported Outcome (PRO) measurements in patients with gastroparesis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Patients who presented to the GI outpatient clinics, in-patient consult service, and outpatient endoscopy centers within the Division of Gastroenterology and Hepatology
Key inclusion criteria (2 listed)
- Patients who presented to the GI outpatient clinics, in-patient consult service, and outpatient endoscopy centers within the Division of Gastroenterology and Hepatology
- Carries a diagnosis of GI motility disorder based on the diagnostic criteria listed in table
Key exclusion criteria (1 listed)
- 1. Coexisting medical conditions that may limiting participation in clinical research trial
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 |
|---|---|---|
| no intervention | Other | – |
Primary outcome
Identification of patients by accurate motility diagnosis
Time frame: .through study completion, an average of 10 years
Motility diagnosis will be made by physicians with specialized in GI Motility, based on consensus diagnostic criteria. The information gathered from the database will be used to help promote future clinical development and research in GI motility disorders.
2 secondary outcomes
Patient Reported Outcome (PRO) Measurements in Patients with Small Intestinal Bacterial Overgrowth (SIBO)
Time frame: through study completion, an average of 10 years
Patient Reported Outcome (PRO) Measurements in Patients with Gastroparesis
Time frame: through study completion, an average of 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. observational registry
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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.
Maureen Schilling contact
John m Wo, MD principal investigator
Indiana 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 Eosinophilic Esophagitis and Gastroesophageal Reflux Disease (GERD), run by Indiana 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lainna Cohen (3172780621, larcohen@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of patients by accurate motility diagnosis (time frame: .through study completion, an average of 10 years). 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 16 Jun 2026.