Exocrine Pancreatic Insufficiency and Functional Dyspepsia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMaria Marta Piskorz
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
fecal elastase
Diagnostic testTo 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 cytokines
Diagnostic testCytokines will be quantified using the Bio-Plex Pro™ Human Cytokine 27-plex commercial kit (Bio-Rad Laboratories, USA) following the kit instructions.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
EPI prevalence
Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with functional dyspepsia
Time frame
At baselineSecondary outcomes
1
Groups comparison (EPI vs non EPI)
Define the clinical characteristics of patients group.
Time frame
At baseline2
Factors associated with exocrine pancreatic insufficiency
To investigate the factors associated with EPI in patients with dysfunctional dyspepsia
Time frame
At baselineLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Maria Marta Piskorz
Lead sponsor
Hospital de Clinicas José de San Martín
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: