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RecruitingNCT04506593Updated Jun 16, 2026

Indiana University Gastrointestinal Motility Diagnosis Registry

An observational study in Eosinophilic Esophagitis, Gastroesophageal Reflux Disease (GERD) and Gastroparesis, sponsored by Indiana University. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Indiana University · Observational

From the registry’s dates

  • Started Nov 2014; still recruiting 12 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Sex
All
01

Study 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 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

  1. Primary Aim: Identification of patients by accurate motility diagnosis

  2. Secondary Aims:

    1. To develop Patient Reported Outcome (PRO) measurements in patients with small intestinal bacterial overgrowth (SIBO)
    2. To develop Patient Reported Outcome (PRO) measurements in patients with gastroparesis
02

Conditions studied

  • Eosinophilic Esophagitis
  • Gastroesophageal Reflux Disease (GERD)
  • Gastroparesis
  • Functional Vomiting
  • Irritable Bowel Syndrome (IBS)
  • Constipation
  • Chronic Intestinal Pseudo-obstruction
  • Fecal Incontinence
  • Small Intestinal Bacterial Overgrowth

Keywords

  • Eosinophilic esophagitis
  • Chronic intestinal pseudo-obstruction
  • Small Bowel dysmotility
  • SIBO
  • Vomiting
  • Functional dyspepsia
  • Functional bloating
  • Gastroparesis
03

In context

Eosinophilic Esophagitis

235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 88 across 85 observational studies indexed under Eosinophilic Esophagitis.

Browse Eosinophilic Esophagitis studies →

Lead sponsor

Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.

Browse Indiana University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients who presented to the GI outpatient clinics, in-patient consult service, and outpatient endoscopy centers within the Division of Gastroenterology and Hepatology
  2. Carries a diagnosis of GI motility disorder based on the diagnostic criteria listed in table

Exclusion criteria

Exclusion Criteria:

1. Coexisting medical conditions that may limiting participation in clinical research trial

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Interventions

  • Otherno intervention
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: .through study completion, an average of 10 years

Secondary outcomes

  1. 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

    Time frame: through study completion, an average of 10 years

  2. 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.

    Time frame: through study completion, an average of 10 years

07

Study locations

1 of 1 sites recruiting
  • Indiana University Health University Hospital
    Indianapolis, Indiana 46202, United States
    Recruiting
    • Maureen Schilling, BA · Contactmaschi@iu.edu · 317-278-2064
    • Thomas V Nowak, MD · Sub investigator
    • John Wo, MD · Principal investigator
    • Joel Wittles, MD · Sub investigator
    • Robert Siwiec, MD · Sub investigator
    • Toyia J Stevenson, MD · Sub investigator
    • Akira Saito, MD · Sub investigator
    • Anne Montero, PhD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No — observational registry

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2014 (actual). Primary completion is estimated for Nov 2026, 144 months after the start.

Of 52 non-industry observational studies under Eosinophilic Esophagitis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 120. This study's planned 144 months is above that.

Counting every sponsor, half of 55 studies reached it within 49 months; a quarter within 22 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2016
First posted
Aug 10, 2020
StartActual
Nov 1, 2014
Primary completionEst.
Nov 2026
CompletionEst.
Nov 2026
Last update
Jun 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04506593
Lead sponsor
Indiana University
Responsible party
John M. Wo (Douglas Rex Professor of Gastroenterology and Hepatology; Director of GI Motility and Neurogastroenterology Unit, Indiana University) — Principal investigator
First posted
Aug 10, 2020
Start date
Nov 1, 2014
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Jun 16, 2026

Study contacts

Lainna Cohen
Contact
larcohen@iu.edu
3172780621
Maureen Schilling
Contact
maschi@iu.edu
John m Wo, MD
principal investigator · Indiana University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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