An observational study in Diarrhea, Exocrine Pancreatic Insufficiency and Abdominal Pain, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by Baylor College of Medicine · Observational
Among 249 studies in Diarrhea with a site in United States — 15 open to participants now, 20 under way, none of them phase 3. Diarrhea · United States.
Among the 249 studies in Diarrhea with a site in United States, this one is the 11th largest by enrollment of the 16 observational ones that give a count, is one of 11 that started in 2015, is one of 16 observational ones, and was the 173rd registered.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
Browse Diarrhea studies →15 of the 249 studies in Diarrhea with a site in United States are open now. Recruiting first, the newest first:
Virginia Polytechnic Institute and State University · Sites in United States
Ages 6 mo+ · Healthy volunteers
Maryam Lustberg · Sites in United States
Ages 18+ · Healthy volunteers
Eli Lilly and Company · Sites in United States, Belgium, Canada and 7 more countries
Ages 18–75
Bausch Health Americas, Inc. · Sites in United States
Ages 6–12
Peach Perfect · Sites in United States
Ages 18–60
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 45 Diarrhea studies recruiting now, 21 (47%) set no upper age limit and 22 (49%) stop at 75 or younger; 19 take children under 18; 15 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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249 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 46 · Phase 2 80 · Phase 3 43 · Phase 4 24
First in 1996; this study’s year is marked. 11 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 142 is below the median of 248 across 103 observational studies indexed under Diarrhea.
Median enrollment 63 across the 223 interventional studies, 190 across the 16 observational. Of the 213 that completed or were terminated, 95 (45%) have results posted.
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99 of 249 have an industry lead sponsor. The 10 most frequent:
Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
Baylor College of Medicine has 4 studies filed under Diarrhea — fewer than ten, so there is no comparison to draw.
10 of the studies in Diarrhea with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01822470Indiana UniversitySmall Intestinal Bacterial Overgrowth: A Prospective Registry | 2026-12 |
| NCT05465629ViomeViome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions | 2026-12 |
| NCT06684470Mayo ClinicNovel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator | 2026-12-19 |
| NCT06801067Memorial Sloan Kettering Cancer CenterA Study of SER-155 to Treat Diarrhea in People on Immunotherapy | 2027-01-24 |
| NCT04826991Temple UniversityWells and Enteric Disease Transmission | 2027-03-31 |
Add all 10 to your calendar (.ics) → With an account.
Among the 249 studies in Diarrhea with a site in United States, from their registry updates:
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The prevalence of exocrine pancreatic insufficiency (EPI) among patients presenting with diarrhea and bloating as their chief complaints is not well studied. Diarrhea and or bloating can be due to different etiologies such as celiac disease and irritable bowel syndrome. However, concomitant EPI can exacerbate these conditions, or be the main cause of the symptoms. Furthermore, some of these diagnoses can be epiphenomena or consequences of EPI. The Investigators hypothesize that EPI will be detected in significant proportion of patients with bloating or diarrhea and that early detection and management of EPI can prevent unnecessary work up for other causes of diarrhea.
Exocrine pancreatic insufficiency (EPI) diagnosis can be challenging due to several reasons. First, the main symptoms of EPI such as diarrhea, loose stool, bloating or weight loss have low specificity because they could be associated with many other conditions such as IBS or celiac disease. Second, EPI could be found concomitantly as an exacerbating factor with other causes of diarrhea and bloating leading to incomplete treatment and increased patient dissatisfaction due to partial resolution of symptoms. Although the prevalence of EPI in general population is not well known, a recent population study in 914 patients from Norway showed up to 10% prevalence of EPI using the measurement of fecal elastase-1 level in elderly. In another study, the prevalence of EPI diagnosed by low fecal elastase-1 in 314 patients with chronic diarrhea who satisfied the Rome II criteria for irritable bowel syndrome diarrhea (IBS-D) was 6.1%.Furthermore, an EPI prevalence of 4.4% (diagnosed by low fecal elastase-1) was documented in 90 patients who had serological and histological evidence of celiac disease. Interestingly, MRI was normal in all patients diagnosed with EPI in this study.
The gold standard tests for diagnosing EPI is three-day fecal fat quantification and determination of the coefficient of fat absorption. The patient is required to keep an intake of 100g of fat for five days and then collect feces for a time period of three days. Direct measurement of pancreatic function test with secreting stimulation is another sensitive test. . However these tests are cumbersome to apply to large number of patients with common complaints. Spot fecal elastase-1 measurement using enzyme linked immunosorbent assay (ELISA) has been shown to be highly sensitive and specific in diagnosing moderate to severe chronic pancreatitis in several studies. The favorable operating characteristics combined with the ease of using of the test makes it a good initial screening test for EPI.
Our preliminary data indicate that a large proportion (10 %) of patients with undiagnosed bloating and or diarrhea have EPI initially detected by low fecal elastase-1 and subsequently confirmed with Endoscopic Ultrasound and or direct measurement of pancreatic function tests. Therefore, Investigators propose to test the hypothesis that including fecal elastase-1 as part of the initial work-up for patients presenting with diarrhea and or bloating will identify patients who are confirmed EPI and may benefit from pancreatic enzyme replacement therapy and limit further unnecessary work up.
Study Population ages 18-80 will be recruited from St. Luke Baylor's Clinic during their clinic visit. Patients will receive full complete details about the research protocol and then will receive a consent form with all steps taken in details for the research. Participating in this research will be voluntary and if the patient decides to participate in the research they will need to sign and date the consent form. Patients to be recruited during the clinic visits are patients of the PI and/or of the Co-Investigators in this study.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prevelance of Pancreatic Insufficency among patients that complain of symptoms of diarrhea and bloating
1- Estimate the prevalence of the spectrum of EPI among patients presenting with diarrhea and bloating as chief complaints using fecal elastase-1 levels.
Time frame: 4-6 Weeks
The record gives a start of Nov 2015, a primary completion of Nov 2021 and a completion of Feb 2022. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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