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Exocrine Pancreatic Insufficiency and Functional Dyspepsia

NCT06756503 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2025-08-08

No results posted yet for this study

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 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).

Conditions

  • Exocrine Pancreatic Insufficiency
  • Dyspepsia

Interventions

DIAGNOSTIC_TEST

fecal elastase

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.

DIAGNOSTIC_TEST

Serum cytokines

Cytokines will be quantified using the Bio-Plex Pro™ Human Cytokine 27-plex commercial kit (Bio-Rad Laboratories, USA) following the kit instructions.

Sponsors & Collaborators

  • Maria Marta Piskorz

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-03-01
Completion
2026-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06756503 on ClinicalTrials.gov