DiarrheaNCT03407534
Detection of Exocrine Pancreatic Insufficiency in Patients With Diarrhea and Bloating
An observational study of Diarrhea and Exocrine Pancreatic Insufficiency, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diarrhea, Exocrine Pancreatic Insufficiency, Abdominal Pain
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 15 Feb 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients aged 18 to 80 years old who presents to the gastroenterology clinic with main complaints of diarrhea
- Patients aged 18-80 years old who presents to the gastroenterology clinic with main complaints of flatulence, and/or bloating
- Patients with known IBS, microscopic colitis or celiac disease diagnosis will be included.
- Patients on Diphenxoylate, loperamide or cholestyramin will be included.
Who cannot join
- Known chronic pancreatitis, recurrent acute pancreatitis or autoimmune pancreatitis.
- Known Pancreatic cancer
- Prior History of distal pancreatictomy or Whipple surgery.
- Prior history of gastric bypass surgery or any Roux en Y gastrojeujunal anastomosis.
- Pregnant Patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Detection of Exocrine Pancreatic Insufficiency in Patients Presenting With Diarrhea and Bloating
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.
Read the detailed description
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.
- Conditions
- Diarrhea, Exocrine Pancreatic Insufficiency, Abdominal Pain
- Keywords
- Exocrine, Pancreatic Insufficiency, Diarrhea, Bloating, Loose Stool
- Medical subject headings
- Diarrhea, Exocrine Pancreatic Insufficiency, Abdominal Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study startNov 2015
- Primary completion9 Nov 2021
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Othman, Baylor College of Medicine
- Investigators
- Mohamed Othman, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407534
- Sponsor's protocol ID
- H-37932
- Status last verified
- May 2022
- First submitted
- 28 Jul 2017
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Keihanian T, Agarwal S, Mansour N, Mercado M, El-Serag HB, Othman MO. Prevalence of Exocrine Pancreatic Insufficiency in Patients with Chronic Diarrhea. Saudi J Med Med Sci. 2025 Apr-Jun;13(2):99-105. doi: 10.4103/sjmms.sjmms_4_25. Epub 2025 Apr 21.
PubMed 40352337
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Exocrine Pancreatic Insufficiency in Patients Presenting With Diarrhea and Bloating
- ClinicalTrials.gov ID
- NCT03407534
- Acronym / sponsor ID
- H-37932
- Conditions
- Diarrhea, Exocrine Pancreatic Insufficiency, Abdominal Pain
- Keywords
- Exocrine, Pancreatic Insufficiency, Diarrhea, Bloating, Loose Stool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 23 Jan 2018 (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 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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Patients aged 18 to 80 years old who presents to the gastroenterology clinic with main complaints of diarrhea
- Patients aged 18-80 years old who presents to the gastroenterology clinic with main complaints of flatulence, and/or bloating
- Patients with known IBS, microscopic colitis or celiac disease diagnosis will be included.
- Patients on Diphenxoylate, loperamide or cholestyramin will be included.
Key exclusion criteria (5 listed)
- Known chronic pancreatitis, recurrent acute pancreatitis or autoimmune pancreatitis.
- Known Pancreatic cancer
- Prior History of distal pancreatictomy or Whipple surgery.
- Prior history of gastric bypass surgery or any Roux en Y gastrojeujunal anastomosis.
- Pregnant Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevelance of Pancreatic Insufficency among patients that complain of symptoms of diarrhea and bloating
Time frame: 4-6 Weeks
1- Estimate the prevalence of the spectrum of EPI among patients presenting with diarrhea and bloating as chief complaints using fecal elastase-1 levels.
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 27 May 2022.
- Derived from this study: PubMed 40352337Keihanian T, Agarwal S, Mansour N, Mercado M, El-Serag HB, Othman MO. Prevalence of Exocrine Pancreatic Insufficiency in Patients with Chronic Diarrhea. Saudi J Med Med Sci. 2025 Apr-Jun;13(2):99-105. doi: 10.4103/sjmms.sjmms_4_25. Epub 2025 Apr 21.
Related trials for Diarrhea
Not yet recruiting
Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months
Acute Watery Diarrhea, Acute Watery Diarrhoea
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
RecruitingPhase 2
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
Immune-related Adverse Event, Diarrhea
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.
Mohamed Othman, MD principal investigator
Baylor College of Medicine
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 Diarrhea and Exocrine Pancreatic Insufficiency, run by Baylor College of Medicine 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 4 inclusion and 5 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 27 May 2022. 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?
Prevelance of Pancreatic Insufficency among patients that complain of symptoms of diarrhea and bloating (time frame: 4-6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03407534, which also lists 1 linked publication.
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 27 May 2022.