Influence of Bile Acids on Bacterial Uptake in Functional Dyspepsia
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|ClinicalTrials.gov Identifier: NCT03296267|
Recruitment Status : Unknown
Verified September 2017 by Universitaire Ziekenhuizen Leuven.
Recruitment status was: Recruiting
First Posted : September 28, 2017
Last Update Posted : October 6, 2017
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of a yet to be identified microorganism inside the epithelium and the lamina propria of a subset of FD patients (unpublished observations), suggesting increased translocation of microorganisms.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.
|Condition or disease||Intervention/treatment||Phase|
|Functional Dyspepsia||Procedure: Gastroduodenoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Translocation of Microorganisms in Duodenal Biopsies of Healthy Volunteers and Patients With Functional Dyspepsia|
|Actual Study Start Date :||January 2, 2017|
|Estimated Primary Completion Date :||April 20, 2018|
|Estimated Study Completion Date :||April 20, 2018|
all participants undergo a gastroduodenoscopy to use the biopsies in an Ussing chamber experiment.
Gastroduodenoscopy with duodenal biospies: A tube is placed via the mouth into the second part of the duodenum. Biopsy forceps is used to take duodenal biopsies.
- Bacterial uptake in the duodenal biopsy measured by fluorescent intensity at the basolateral side of the ussing chamber setup. [ Time Frame: 120 minutes ]duodenal uptake of fluorescein conjugated microorganisms
- duodenal permeability assessed by measuring transepithelial electrical resistance in the Ussing chamber setup [ Time Frame: 120 minutes ]transepithelial electrical resistance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296267
|Contact: Dorien Beeckmans, PhD||+3216 37 73 email@example.com|
|Translational Research center for Gastrointestinal Disorders (TARGID)||Recruiting|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Contact: Dorien Beeckmans +3216 37 73 11 firstname.lastname@example.org|
|Principal Investigator:||Jan Tack, Professor||KU Leuven|