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Influence of Bile Acids on Bacterial Uptake in Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT03296267
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:

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of a yet to be identified microorganism inside the epithelium and the lamina propria of a subset of FD patients (unpublished observations), suggesting increased translocation of microorganisms.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

Detailed Description:
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.

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Indigestion

Arm Intervention/treatment
gastroduodenoscopy
all participants undergo a gastroduodenoscopy to use the biopsies in an Ussing chamber experiment.
Procedure: Gastroduodenoscopy
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. duodenal permeability assessed by measuring transepithelial electrical resistance in the Ussing chamber setup [ Time Frame: 120 minutes ]
    transepithelial electrical resistance



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Three days before the measurement: no smoking and drinking alcohol
  • 12 hours before the measurement: no drinking and eating

Exclusion Criteria:

  • symptoms or history of gastrointestinal disease
  • first degree relatives with celiac disease
  • diabetes mellitus
  • allergy/atopy (eczema, asthma, allergic rhinoconjunctivitis)
  • coagulation disorders/anticoagulant therapy
  • first degree relatives with Crohn's disease or type I diabetes mellitus.
  • intake of antihistamines, ketotifen, cromoglycate, acetylsalicylates, NSAIDs, anticholinergics, theophylline, β2-agonists, codeine or opioid derivatives for at least 2 weeks prior to the gastroscopy
  • Intake of steroid or immunosuppressive drugs in the last 6 months

Information from the National Library of Medicine

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


Contacts
Contact: Dorien Beeckmans, PhD +3216 37 73 11 dorien.beeckmans@kuleuven.be

Locations
Belgium
Translational Research center for Gastrointestinal Disorders (TARGID) Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Dorien Beeckmans    +3216 37 73 11    dorien.beeckmans@kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Jan Tack, Professor KU Leuven

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03296267     History of Changes
Other Study ID Numbers: s56880
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitaire Ziekenhuizen Leuven:
bile acid
bacterial uptake

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Bile Acids and Salts
Gastrointestinal Agents