Influence of Bile Acids on Bacterial Uptake in Functional Dyspepsia

NCT03296267 | Completed

• 1 other identifier: s56880
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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of a yet to be identified microorganism inside the epithelium and the lamina propria of a subset of FD patients (unpublished observations), suggesting increased translocation of microorganisms.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

Conditions

Functional Dyspepsia

Keywords

bile acid; bacterial uptake

Outcome Measures

Primary Outcomes (1)

• 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

  120 minutes

Secondary Outcomes (1)

• duodenal permeability assessed by measuring transepithelial electrical resistance in the Ussing chamber setup

  120 minutes

Study Arms (1)

gastroduodenoscopy

OTHER

all participants undergo a gastroduodenoscopy to use the biopsies in an Ussing chamber experiment.

Procedure: Gastroduodenoscopy

Interventions

Gastroduodenoscopy PROCEDURE

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.

gastroduodenoscopy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Translational Research center for Gastrointestinal Disorders (TARGID)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Officials

• Jan Tack, Professor

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 28, 2017
• Study Start: January 2, 2017
• Primary Completion: April 27, 2018
• Study Completion: August 27, 2018
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)