Influence of Bile Acids on Bacterial Uptake in Functional Dyspepsia
Primary Purpose
Functional Dyspepsia
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Gastroduodenoscopy
Sponsored by
About this trial
This is an interventional basic science trial for Functional Dyspepsia focused on measuring bile acid, bacterial uptake
Eligibility 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
Sites / Locations
- Translational Research center for Gastrointestinal Disorders (TARGID)Recruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
gastroduodenoscopy
Arm Description
all participants undergo a gastroduodenoscopy to use the biopsies in an Ussing chamber experiment.
Outcomes
Primary Outcome Measures
Bacterial uptake in the duodenal biopsy measured by fluorescent intensity at the basolateral side of the ussing chamber setup.
duodenal uptake of fluorescein conjugated microorganisms
Secondary Outcome Measures
duodenal permeability assessed by measuring transepithelial electrical resistance in the Ussing chamber setup
transepithelial electrical resistance
Full Information
NCT ID
NCT03296267
First Posted
September 18, 2017
Last Updated
October 4, 2017
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT03296267
Brief Title
Influence of Bile Acids on Bacterial Uptake in Functional Dyspepsia
Official Title
Translocation of Microorganisms in Duodenal Biopsies of Healthy Volunteers and Patients With Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
April 20, 2018 (Anticipated)
Study Completion Date
April 20, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
bile acid, bacterial uptake
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
gastroduodenoscopy
Arm Type
Other
Arm Description
all participants undergo a gastroduodenoscopy to use the biopsies in an Ussing chamber experiment.
Intervention Type
Procedure
Intervention Name(s)
Gastroduodenoscopy
Intervention Description
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 Measure Information:
Title
Bacterial uptake in the duodenal biopsy measured by fluorescent intensity at the basolateral side of the ussing chamber setup.
Description
duodenal uptake of fluorescein conjugated microorganisms
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
duodenal permeability assessed by measuring transepithelial electrical resistance in the Ussing chamber setup
Description
transepithelial electrical resistance
Time Frame
120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorien Beeckmans, PhD
Phone
+3216 37 73 11
Email
dorien.beeckmans@kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Tack, Professor
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Translational Research center for Gastrointestinal Disorders (TARGID)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorien Beeckmans
Phone
+3216 37 73 11
Email
dorien.beeckmans@kuleuven.be
12. IPD Sharing Statement
Plan to Share IPD
No
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Influence of Bile Acids on Bacterial Uptake in Functional Dyspepsia
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