Exocrine Pancreatic Insufficiency and Functional Dyspepsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Detection of Exocrine Pancreatic Insufficiency in Patients With Diarrhea and Bloating

NCT03407534

Diarrhea Exocrine Pancreatic Insufficiency Abdominal Pain

COMPLETED

Effect of Secretin in Functional Dyspepsia and Healthy Subjects

NCT03617861

Dyspepsia Healthy

COMPLETED PHASE1/PHASE2

PE-1 in the Diagnosis of Pancreatic Exocrine Insufficiency

NCT05791110

Pancreatic Exocrine Insufficiency

COMPLETED NA

Gastrointestinal Hormone Secretion, Intestinal Permeability and Short Bowel Syndrome

NCT07235670

Short Bowel Syndrome Intestinal Resection

COMPLETED NA

Endoscopic Ultrasound Compared With Pancreatic Function Testing for Diagnosis of Chronic Pancreatitis

NCT00651053

Chronic Pancreatitis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Exocrine Pancreatic Insufficiency Dyspepsia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No