Functional Dyspepsia Clinical Trial
Official title:
Translocation of Microorganisms in Duodenal Biopsies of Healthy Volunteers and Patients With Functional Dyspepsia
In up to half of patients seen by gastroenterologists, routine examinations fail to find an
underlying organic, systemic, or metabolic disease that readily explains the symptoms. These
patients are referred to as patients with disorders of gastrointestinal function, of which
functional dyspepsia (FD) is one of the most common. Despite intensive research to
investigate various pathophysiological mechanisms of this disease, the pathogenesis remains
obscure. The investigators recently demonstrated increased duodenal permeability in FD
patients, as assessed by mounting routine endoscopic duodenal biopsy specimens into Ussing
chambers to measure transepithelial electrical resistance and passage of a paracellular
fluorescent probe. Impaired intestinal barrier function can lead to increased uptake of
luminal substances which can induce an immunological response in the mucosa. Interestingly,
using transmission electron microscopy (TEM) in duodenal biopsies, the investigators recently
observed the presence of a yet to be identified microorganism inside the epithelium and the
lamina propria of a subset of FD patients (unpublished observations), suggesting increased
translocation of microorganisms.
The aim of the project is to investigate whether FD patients display increased translocation
of microorganisms in duodenal biopsies. The investigators will also test the effect of bile
acid on translocation of microorganisms and therefore include 20 FD patients and 20 age- and
gender-matched healthy volunteers in this study.
The participants will be expected on the department endoscopy of the University Hospital Gasthuisberg, Leuven, Belgium. They are asked to fill in a bundle of questionnaires concerning physical complaints, depression, anxiety (disturbances), pain/disease, body/interoceptive awareness, trauma/abuse and personality. Endoscopy will be performed and up to 8 biopsies will be obtained from the duodenum. All endoscopies will be performed by an experienced endoscopist. Biopsies will be mounted in Ussing chambers and the mucosal compartment will be exposed to commercially available fluorescein-conjugated microorganisms. Uptake of microorganisms will be evaluated by analyzing the serosal compartment and by confocal microscopy of the biopsies. These experiments will also be performed in combination with exposure to bile acids separately and jointly, to assess if bacterial translocation can be exacerbated by these endogenous luminal factors individually and synergistically. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04656730 -
Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas
|
Phase 4 | |
Completed |
NCT04464369 -
Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial
|
Phase 4 | |
Completed |
NCT01671670 -
Acupuncture for Patients With Function Dyspepsia
|
Phase 2/Phase 3 | |
Completed |
NCT00987805 -
Efficacy of Banhasasim-tang on Functional Dyspepsia
|
Phase 4 | |
Completed |
NCT00761358 -
To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia
|
Phase 3 | |
Completed |
NCT00693407 -
Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation
|
N/A | |
Recruiting |
NCT01240096 -
Mirtazapine Versus Placebo in Functional Dyspepsia
|
Phase 4 | |
Recruiting |
NCT04540549 -
Effects of Exercise on Functional Dyspepsia Based on Rome IV
|
N/A | |
Recruiting |
NCT03652571 -
Nortriptyline for the Treatment of Functional Dyspepsia
|
Phase 3 | |
Recruiting |
NCT06068114 -
Gastric Pathophysiology in Diabetes
|
||
Recruiting |
NCT03825692 -
International Clinical Study of Zhizhu Kuanzhong Capsule
|
Phase 4 | |
Not yet recruiting |
NCT04548011 -
Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia
|
N/A | |
Terminated |
NCT02567578 -
A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia
|
Phase 2 | |
Completed |
NCT03007433 -
Assessment of GI Function to a Large Test Meal by Non-invasive Imaging
|
N/A | |
Active, not recruiting |
NCT00990405 -
Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia
|
Phase 4 | |
Completed |
NCT00404534 -
Helicobacter Eradication Relief of Dyspeptic Symptoms
|
Phase 3 | |
Completed |
NCT03043625 -
Visceral Manipulation Treatment to Patients With Non-specific Neck Pain With Functional Dyspepsia
|
N/A | |
Completed |
NCT03225248 -
Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia
|
Phase 3 | |
Recruiting |
NCT05587127 -
Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
|
N/A | |
Recruiting |
NCT01021475 -
Does Visceral Manipulation Works in Treating Functional Dyspepsia?
|
Phase 1 |