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Search / Trial NCT02522000

Functional Dyspepsia and Symptom Perception

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Aug 12, 2015

Trial Information

Current as of May 23, 2025

Unknown status

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Healthy volunteers
  • Inclusion criteria:
  • - No gastrointestinal symptoms or history of gastrointestinal disease meeting ROME III criteria for functional dyspepsia and Irritable Bowel Syndrome (IBS).
  • Exclusion criteria:
  • Inability to stop the intake of nonsteroidal antiinflammatory drugs (NSAIDs) within 14 days prior to endoscopy and within two days prior to multi-sugar test.
  • Inability to stop the intake of medication affecting gastrointestinal function (e.g. proton pump inhibitors, prokinetics, laxatives) within 5 days prior to endoscopy, multi-sugar test and combined meal- and gastric emptying test
  • Current use of antidepressants
  • Medical history of diabetes mellitus
  • Medical history of coeliac disease
  • Organic disease at upper gastrointestinal endoscopy (i.e. erosive esophagitis, Barrett's esophagus, benign esophageal stricture, Schatzki ring, esophageal carcinoma, esophageal candidiasis, gastric ulcer, gastric erosions, gastric cancer, duodenal erosions or duodenal ulcer)
  • First-degree family members with diabetes mellitus type I, coeliac disease, Crohn's disease or ulcerative colitis
  • Medical history of food allergy or anamnestic evidence of food allergy
  • Presence of coagulation disorders or use of the following anticoagulants: coumarin derivates, new oral anticoagulants (NOACs: dabigatran, apixaban and rivaroxaban), and clopidogrel (Patients or healthy controls using calcium carbasalate (acetylsalicylic acid 100mg 1dd1) are eligible to participate in the study. Patients or healthy controls using higher doses of calcium carbasalate will be excluded from the study).
  • Dieting
  • Pregnancy or lactation
  • Smoking
  • Excessive alcohol use (\>20 alcoholic consumptions/week) and inability to avoid use of alcohol in the 2 days prior to endoscopy and multi-sugar test
  • Functional dyspepsia patients
  • Inclusion criteria:
  • - Patients referred for upper gastrointestinal endoscopy by either general practitioners or physicians from the gastroenterology outpatient clinic and meeting ROME III criteria for functional dyspepsia.
  • Exclusion criteria:
  • Inability to stop the intake of nonsteroidal antiinflammatory drugs (NSAIDs) within 14 days prior to endoscopy and within two days prior to multi-sugar test.
  • Inability to stop the intake of medication affecting gastrointestinal function (e.g. proton pump inhibitors, prokinetics, laxatives) within 5 days prior to endoscopy, multi-sugar test and combined meal- and gastric emptying test
  • Current use of antidepressants
  • Medical history of diabetes mellitus
  • Medical history of coeliac disease
  • Organic disease at upper gastrointestinal endoscopy (i.e. erosive esophagitis, Barrett's esophagus, benign esophageal stricture, Schatzki ring, esophageal carcinoma, esophageal candidiasis, gastric ulcer, gastric erosions, gastric cancer, duodenal erosions or duodenal ulcer)
  • First-degree family members with diabetes mellitus type I, coeliac disease, Crohn's disease or ulcerative colitis
  • Medical history of food allergy or anamnestic evidence of food allergy
  • Presence of coagulation disorders or use of the following anticoagulants: coumarin derivates, new oral anticoagulants (NOACs: dabigatran, apixaban and rivaroxaban), and clopidogrel (Patients or healthy controls using calcium carbasalate (acetylsalicylic acid 100mg 1dd1) are eligible to participate in the study. Patients or healthy controls using higher doses of calcium carbasalate will be excluded from the study).
  • Dieting
  • Pregnancy or lactation
  • Smoking
  • Excessive alcohol use (\>20 alcoholic consumptions/week) and inability to avoid use of alcohol in the 2 days prior to endoscopy and multi-sugar test

About Maastricht University Medical Center

Maastricht University Medical Center (MUMC+) is a leading academic medical center in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, MUMC+ integrates cutting-edge scientific inquiry with clinical practice, focusing on a wide range of medical disciplines. The center emphasizes collaboration among multidisciplinary teams, fostering an environment that promotes excellence in patient care and the translation of research findings into clinical applications. MUMC+ is dedicated to improving health outcomes and enhancing quality of life through rigorous clinical investigations and the development of novel therapeutic strategies.

Locations

Maastricht, , Netherlands

Sittard Geleen, , Netherlands

Tilburg, , Netherlands

Patients applied

0 patients applied

Trial Officials

Jose Conchillo, MD, PhD

Principal Investigator

Maastricht University Medical Center, Maastricht, The Netherlands

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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