Exocrine Pancreatic InsufficiencyNCT06756503
Exocrine Pancreatic Insufficiency and Functional Dyspepsia
An observational study of Exocrine Pancreatic Insufficiency and Dyspepsia, run by Maria Marta Piskorz.
Trial summary
The goal of this observational study is to learn about the prevalence of exocrine pancreatic insufficiency in patients with functional dyspepsia . . The main questions it aims to answer are: What is the prevalence of exocrine pancreatic insufficiency (EPI) in patients with functional dyspepsia? Wich are the clinical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Exocrine Pancreatic Insufficiency, Dyspepsia
- What is being tested?
- fecal elastase and Serum cytokines
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Aug 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age diagnosed with functional dyspepsia based on Rome IV criteria, who have been excluded for organic, metabolic, and medication-related causes (NSAIDs), and who test negative for H. pylori. The Rome IV criteria for functional dyspepsia include the presence of one or more of the following symptoms: bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning, occurring at least once a week in the last three months with symptom onset at least six months prior to diagnosis.
Who may be able to join
- Patients over 18 years of age diagnosed with functional dyspepsia based on Rome IV criteria, who have been excluded for organic, metabolic, and medication-related causes (NSAIDs), and who test negative for H. pylori.
Who cannot join
- Pregnancy or lactation
- Organic diseases of the digestive tract (celiac disease, inflammatory bowel diseases, neoplasms, positive for H. pylori)
- Uncontrolled systemic diseases (diabetes mellitus, hypo- or hyperthyroidism, cancer, etc.)
- Lack of informed consent
- Severe psychiatric disorders, defined based on the DSM-5
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevalence and Clinical Characteristics of Exocrine Pancreatic Insufficiency in Patients With Functional Dyspepsia
The goal of this observational study is to learn about the prevalence of exocrine pancreatic insufficiency in patients with functional dyspepsia .
. The main questions it aims to answer are: What is the prevalence of exocrine pancreatic insufficiency (EPI) in patients with functional dyspepsia? Wich are the clinical characteristics associated with (EPI) in patients with functional dyspepsia? Patients diagnosed with functional dyspepsia will undergo an evaluation of clinical symptoms and fecal elastase determination. In those with fecal elastase levels below 100 µg/g, an endoscopic ultrasound and other assessments will be performed to define the cause of exocrine pancreatic insufficiency (EPI).
Read the detailed description
Functional dyspepsia and exocrine pancreatic insufficiency (EPI) represent two gastrointestinal disorders that can occur concomitantly. Functional dyspepsia involves chronic digestive symptoms without identifiable organic causes, while EPI refers to insufficient pancreatic enzyme production for adequate digestion.
Functional dyspepsia is prevalent in the general population, with estimates ranging from 10% to 30% based on various studies. Defined by Rome IV criteria, functional dyspepsia includes epigastric pain, early satiety, or postprandial bloating in the absence of organic conditions. EPI may occur more frequently in individuals with functional dyspepsia. Small studies have identified EPI as a potential mechanism contributing to symptoms. Dyspepsia has been identified as an independent predictor of EPI in research exploring this condition within irritable bowel syndrome.
Recent findings suggest a possible association between EPI and functional dyspepsia. Research by Tahtaci et al. (2018) evaluated EPI in a cohort with functional dyspepsia, revealing that approximately 15% of these patients met criteria for EPI. These findings underscore the importance of evaluating EPI in cases of persistent symptoms unresponsive to conventional treatment. Early identification of EPI may enhance therapeutic management and improve quality of life in this population.
Further studies remain necessary to elucidate the relationship between functional dyspepsia and EPI, establish precise diagnostic criteria, and optimize treatment strategies.
This study adopts a prospective, cross-sectional, and analytical design. A total of 65 patients with functional dyspepsia will undergo assessments including:
- Symptom severity questionnaires addressing depression, anxiety, somatization, and stress.
- Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q).
- Alcohol and tobacco use (anticipated to correlate with higher prevalence of chronic pancreatitis).
- Measurements of weight, height, and abdominal circumference.
- Fecal elastase-1 (Fel-1) testing.
- Serum analysis of pro- and anti-inflammatory cytokines.
- Hydrogen and methane breath testing for small intestinal bacterial overgrowth (SIBO).
EPI will be diagnosed based on fecal elastase-1 concentrations <100 µg/g or values between 100 and 200 µg/g in conjunction with abnormalities in additional pancreatic pathology tests, including serum albumin, vitamin E, vitamin D, vitamin A, folic acid, iron, transferrin, calcium, magnesium, or evidence of malnutrition from anthropometric measurements by a nutritionist. Fecal elastase values ≥200 µg/g will be considered normal.
Patients with fecal elastase values below 200 will undergo additional testing, including:
- Proteinogram, vitamin E, vitamin D, vitamin A, vitamin K, folic acid, B12, calcium, magnesium, zinc, iron profile, and nutritional assessment with anthropometry.
For patients diagnosed with EPI, additional evaluations will include:
- IgG4, alpha-1 antitrypsin, and endoscopic ultrasound.
Based on these parameters, patients will be categorized into EPI and non-EPI groups.
- Conditions
- Exocrine Pancreatic Insufficiency, Dyspepsia
- Being tested
- fecal elastase, Serum cytokines
- Keywords
- Exocrine pancreatic insufficiency, Functional dyspepsia, Fecal elastase
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal elastaseDiagnostic test
To investigate exocrine pancreatic insufficiency (EPI), all patients will be asked to provide a stool sample for fecal elastase (Fel-1) analysis. Participants will be instructed to collect their stool sample in a sterile, disposable plastic container and submit it to the Gastroenterology Chemistry Laboratory (Litwin Laboratory) for processing and analysis. Based on previously published reports, samples will be refrigerated at 4-8 °C for no more than 48 hours. The concentration of Fel-1 in all samples will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (ScheBo-Pancreatic Elastase 1™, Giessen, Germany), with fecal elastase extracted and analyzed according to the manufacturer's instructions.
Serum cytokinesDiagnostic test
Cytokines will be quantified using the Bio-Plex Pro™ Human Cytokine 27-plex commercial kit (Bio-Rad Laboratories, USA) following the kit instructions.
What is being measured
The primary outcome is the main question the study is designed to answer.
EPI prevalence
Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with functional dyspepsia
Measured: At baseline
Secondary outcomes (2)
Groups comparison (EPI vs non EPI)
Define the clinical characteristics of patients group.
Measured: At baseline
Factors associated with exocrine pancreatic insufficiency
To investigate the factors associated with EPI in patients with dysfunctional dyspepsia
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Exocrine Pancreatic InsufficiencyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Marta Piskorz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Marta Piskorz, Hospital de Clinicas José de San Martín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756503
- Sponsor's protocol ID
- HCJSM-10-2024
- Status last verified
- Aug 2025
- First submitted
- 22 Oct 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data sets, including the redacted study protocol, redacted statistical analysis plan, and individual participant data supporting the results reported in this article, will be made available within 3 months from initial request to researchers who provide a methodologically sound proposal. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization.
Publications
Dominguez-Munoz JE. Diagnosis and treatment of pancreatic exocrine insufficiency. Curr Opin Gastroenterol. 2018 Sep;34(5):349-354. doi: 10.1097/MOG.0000000000000459.
PubMed 29889111Johnson CD, Williamson N, Janssen-van Solingen G, Arbuckle R, Johnson C, Simpson S, Staab D, Dominguez-Munoz E, Levy P, Connett G, Lerch MM. Psychometric evaluation of a patient-reported outcome measure in pancreatic exocrine insufficiency (PEI). Pancreatology. 2019 Jan;19(1):182-190. doi: 10.1016/j.pan.2018.11.013. Epub 2018 Nov 27.
PubMed 30528109Phillips ME, Hopper AD, Leeds JS, Roberts KJ, McGeeney L, Duggan SN, Kumar R. Consensus for the management of pancreatic exocrine insufficiency: UK practical guidelines. BMJ Open Gastroenterol. 2021 Jun;8(1):e000643. doi: 10.1136/bmjgast-2021-000643.
PubMed 34140324Tack J, Talley NJ, Camilleri M, Holtmann G, Hu P, Malagelada JR, Stanghellini V. Functional gastroduodenal disorders. Gastroenterology. 2006 Apr;130(5):1466-79. doi: 10.1053/j.gastro.2005.11.059.
PubMed 16678560Ford AC, Marwaha A, Lim A, Moayyedi P. What is the prevalence of clinically significant endoscopic findings in subjects with dyspepsia? Systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2010 Oct;8(10):830-7, 837.e1-2. doi: 10.1016/j.cgh.2010.05.031. Epub 2010 Jun 10.
PubMed 20541625Olmos JI, Piskorz MM, Litwin N, Schaab S, Tevez A, Bravo-Velez G, Uehara T, Hashimoto H, Rey E, Sorda JA, Olmos JA. Exocrine Pancreatic Insufficiency is Undiagnosed in Some Patients with Diarrhea-Predominant Irritable Bowel Syndrome Using the Rome IV Criteria. Dig Dis Sci. 2022 Dec;67(12):5666-5675. doi: 10.1007/s10620-022-07568-8. Epub 2022 Jun 15.
PubMed 35704255
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Clinical Characteristics of Exocrine Pancreatic Insufficiency in Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT06756503
- Acronym / sponsor ID
- HCJSM-10-2024
- Conditions
- Exocrine Pancreatic Insufficiency, Dyspepsia
- Keywords
- Exocrine pancreatic insufficiency, Functional dyspepsia, Fecal elastase
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Maria Marta PiskorzUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 3 Jan 2025 (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 goal of this observational study is to learn about the prevalence of exocrine pancreatic insufficiency in patients with functional dyspepsia .
. The main questions it aims to answer are: What is the prevalence of exocrine pancreatic insufficiency (EPI) in patients with functional dyspepsia? Wich are the clinical characteristics associated with (EPI) in patients with functional dyspepsia? Patients diagnosed with functional dyspepsia will undergo an evaluation of clinical symptoms and fecal elastase determination. In those with fecal elastase levels below 100 µg/g, an endoscopic ultrasound and other assessments will be performed to define the cause of exocrine pancreatic insufficiency (EPI).
Detailed description
Functional dyspepsia and exocrine pancreatic insufficiency (EPI) represent two gastrointestinal disorders that can occur concomitantly. Functional dyspepsia involves chronic digestive symptoms without identifiable organic causes, while EPI refers to insufficient pancreatic enzyme production for adequate digestion.
Functional dyspepsia is prevalent in the general population, with estimates ranging from 10% to 30% based on various studies. Defined by Rome IV criteria, functional dyspepsia includes epigastric pain, early satiety, or postprandial bloating in the absence of organic conditions. EPI may occur more frequently in individuals with functional dyspepsia. Small studies have identified EPI as a potential mechanism contributing to symptoms. Dyspepsia has been identified as an independent predictor of EPI in research exploring this condition within irritable bowel syndrome.
Recent findings suggest a possible association between EPI and functional dyspepsia. Research by Tahtaci et al. (2018) evaluated EPI in a cohort with functional dyspepsia, revealing that approximately 15% of these patients met criteria for EPI. These findings underscore the importance of evaluating EPI in cases of persistent symptoms unresponsive to conventional treatment. Early identification of EPI may enhance therapeutic management and improve quality of life in this population.
Further studies remain necessary to elucidate the relationship between functional dyspepsia and EPI, establish precise diagnostic criteria, and optimize treatment strategies.
This study adopts a prospective, cross-sectional, and analytical design. A total of 65 patients with functional dyspepsia will undergo assessments including:
- Symptom severity questionnaires addressing depression, anxiety, somatization, and stress.
- Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q).
- Alcohol and tobacco use (anticipated to correlate with higher prevalence of chronic pancreatitis).
- Measurements of weight, height, and abdominal circumference.
- Fecal elastase-1 (Fel-1) testing.
- Serum analysis of pro- and anti-inflammatory cytokines.
- Hydrogen and methane breath testing for small intestinal bacterial overgrowth (SIBO).
EPI will be diagnosed based on fecal elastase-1 concentrations <100 µg/g or values between 100 and 200 µg/g in conjunction with abnormalities in additional pancreatic pathology tests, including serum albumin, vitamin E, vitamin D, vitamin A, folic acid, iron, transferrin, calcium, magnesium, or evidence of malnutrition from anthropometric measurements by a nutritionist. Fecal elastase values ≥200 µg/g will be considered normal.
Patients with fecal elastase values below 200 will undergo additional testing, including:
- Proteinogram, vitamin E, vitamin D, vitamin A, vitamin K, folic acid, B12, calcium, magnesium, zinc, iron profile, and nutritional assessment with anthropometry.
For patients diagnosed with EPI, additional evaluations will include:
- IgG4, alpha-1 antitrypsin, and endoscopic ultrasound.
Based on these parameters, patients will be categorized into EPI and non-EPI groups.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age diagnosed with functional dyspepsia based on Rome IV criteria, who have been excluded for organic, metabolic, and medication-related causes (NSAIDs), and who test negative for H. pylori. The Rome IV criteria for functional dyspepsia include the presence of one or more of the following symptoms: bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning, occurring at least once a week in the last three months with symptom onset at least six months prior to diagnosis.
Key inclusion criteria (1 listed)
- Patients over 18 years of age diagnosed with functional dyspepsia based on Rome IV criteria, who have been excluded for organic, metabolic, and medication-related causes (NSAIDs), and who test negative for H. pylori.
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Organic diseases of the digestive tract (celiac disease, inflammatory bowel diseases, neoplasms, positive for H. pylori)
- Uncontrolled systemic diseases (diabetes mellitus, hypo- or hyperthyroidism, cancer, etc.)
- Lack of informed consent
- Severe psychiatric disorders, defined based on the DSM-5
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 |
|---|---|---|
| fecal elastaseTo investigate exocrine pancreatic insufficiency (EPI), all patients will be asked to provide a stool sample for fecal elastase (Fel-1) analysis. Participants will be instructed to collect their stool sample in a sterile, disposable plastic container and submit it to the Gastroenterology Chemistry Laboratory (Litwin Laboratory) for processing and analysis. Based on previously published reports, samples will be refrigerated at 4-8 °C for no more than 48 hours. The concentration of Fel-1 in all samples will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (ScheBo-Pancreatic Elastase 1™, Giessen, Germany), with fecal elastase extracted and analyzed according to the manufacturer's instructions. | Diagnostic test | – |
| Serum cytokinesCytokines will be quantified using the Bio-Plex Pro™ Human Cytokine 27-plex commercial kit (Bio-Rad Laboratories, USA) following the kit instructions. | Diagnostic test | – |
Primary outcome
EPI prevalence
Time frame: At baseline
Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with functional dyspepsia
2 secondary outcomes
Groups comparison (EPI vs non EPI)
Time frame: At baseline
Factors associated with exocrine pancreatic insufficiency
Time frame: At baseline
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 8 Aug 2025.
- Results publication: PubMed 29889111Dominguez-Munoz JE. Diagnosis and treatment of pancreatic exocrine insufficiency. Curr Opin Gastroenterol. 2018 Sep;34(5):349-354. doi: 10.1097/MOG.0000000000000459.
- Results publication: PubMed 30528109Johnson CD, Williamson N, Janssen-van Solingen G, Arbuckle R, Johnson C, Simpson S, Staab D, Dominguez-Munoz E, Levy P, Connett G, Lerch MM. Psychometric evaluation of a patient-reported outcome measure in pancreatic exocrine insufficiency (PEI). Pancreatology. 2019 Jan;19(1):182-190. doi: 10.1016/j.pan.2018.11.013. Epub 2018 Nov 27.
- Results publication: PubMed 34140324Phillips ME, Hopper AD, Leeds JS, Roberts KJ, McGeeney L, Duggan SN, Kumar R. Consensus for the management of pancreatic exocrine insufficiency: UK practical guidelines. BMJ Open Gastroenterol. 2021 Jun;8(1):e000643. doi: 10.1136/bmjgast-2021-000643.
- Results publication: PubMed 16678560Tack J, Talley NJ, Camilleri M, Holtmann G, Hu P, Malagelada JR, Stanghellini V. Functional gastroduodenal disorders. Gastroenterology. 2006 Apr;130(5):1466-79. doi: 10.1053/j.gastro.2005.11.059.
- Results publication: PubMed 20541625Ford AC, Marwaha A, Lim A, Moayyedi P. What is the prevalence of clinically significant endoscopic findings in subjects with dyspepsia? Systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2010 Oct;8(10):830-7, 837.e1-2. doi: 10.1016/j.cgh.2010.05.031. Epub 2010 Jun 10.
- Results publication: PubMed 35704255Olmos JI, Piskorz MM, Litwin N, Schaab S, Tevez A, Bravo-Velez G, Uehara T, Hashimoto H, Rey E, Sorda JA, Olmos JA. Exocrine Pancreatic Insufficiency is Undiagnosed in Some Patients with Diarrhea-Predominant Irritable Bowel Syndrome Using the Rome IV Criteria. Dig Dis Sci. 2022 Dec;67(12):5666-5675. doi: 10.1007/s10620-022-07568-8. Epub 2022 Jun 15.
- Individual participant dataSharing planned: No. The data sets, including the redacted study protocol, redacted statistical analysis plan, and individual participant data supporting the results reported in this article, will be made available within 3 months from initial request to researchers who provide a methodologically sound proposal. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Exocrine Pancreatic Insufficiency and Dyspepsia, run by Maria Marta Piskorz.
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 1 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: opening soon, as of the sponsor's last update on 8 Aug 2025. 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?
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 MARIA M PISKORZ, MD (+5491133192885, neurogastrohc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EPI prevalence (time frame: At baseline). 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 NCT06756503, which also lists 6 linked publications.
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 8 Aug 2025.