Confocal Laser Endomicroscopy to Determine Influence of Food Antigens on Mucosal Integrity

NCT05056610 | Completed

• 1 other identifier: Friedrich-Alexander-University
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is mainly associated with food intolerance and presents a particular challenge in gastrointestinal practice. The clinical symptoms are often associated by patients with the consumption of certain foods. This leads to strict elimination diets, and often without identification of the triggering food. In particular, the avoidance of wheat yields a relief of the clinical symptoms in many patients. Nevertheless, it is unclear which components of wheat are responsible for the symptoms. Besides the glutens, other wheat proteins, such as the amylase trypsin inhibitors, but also carbohydrates are discussed as triggers of the diseases. Confocal laser endomicroscopy (CLE) is a new diagnostic method for detecting the local effect of food on the mucosa. CLE enables microscopic assessment of the mucosa already during an endoscopic examination and also allows statements to be made about intestinal permeability through changes in the influx of fluorescein into the intestinal lumen. In the course of the study, diluted food solutions are applied to the mucosa after a detailed assessment of the mucosa via the endoscope. The changes in mucosa and permeability are observed and documented. Tissue samples are then taken for histopathological assessment of the degree of inflammation. Further biopsies are taken and cultured in vitro to produce human organoids. The organoids are stimulated with the food. Changes in proliferation, gene and cytokine expression are determined. The aim of the proposed project is to investigate the influence of the main allergens, e.g. wheat, soy, milk, yeast and chicken egg white on the intestinal mucosa. The data obtained will be compared with the histopathological findings and the in vitro data in the human organoid model. The long-term goal is to establish a valid patient-based rapid detection method for the detection of the triggering substances in patients with IBS or food intolerances.

Conditions

Irritable Bowel Syndrome; Food Sensitivity; Healthy Controls

Keywords

confocal laser endomicroscopy; organoids; intestinal permeability

Outcome Measures

Primary Outcomes (2)

• Correlation of the intestinal barriere defects determined by CLE with histopathological data

  Correlation of the histopathologically confirmed inflammation and mucosal damage with in vivo data evaluated by CLE. In vivo damage will be reported and evaluated by efflux of fluorescein into the gut lumen and endothel cell shedding.

  2 years

• Determination of patients with IBS and response to food antigens

  Determination of numbers of patients with IBS who show a response or change in permeability after application of the food antigens (wheat, soy, milk, yeast, chicken egg white) in CLE

  2 years

Secondary Outcomes (2)

• in vitro stimulation of intestinal organoids

  2 years

• correlation of data between organoids and CLE

  2 years

Study Arms (2)

Patients with IBS or FI

EXPERIMENTAL

Food antigens are added to duodenal mucosa during CLE

Other: food antigens on duodenal mucosa

healthy controls

EXPERIMENTAL

Food antigens are added to duodenal mucosa during CLE

Other: food antigens on duodenal mucosa

Interventions

food antigens on duodenal mucosa OTHER

Administration of food antigens on duodenal mucosa and determining the response through confocal laser endomicroscopy

Patients with IBS or FI; healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent
• patients with IBS who fulfil the criteria according to Rome IV
• patients with suspected IBS who undergo gastroduodenoscopy for diagnosis of IBS

You may not qualify if:

• lack of written consent
• patients with known allergy to fluorescein.
• Patients with carcinoma, liver disease, proven bacterial overgrowth
• Patients with diabetes mellitus
• Patients with severe cardiovascular disease or multiple concomitant drug therapy (beta-blockers)
• Patients with wheat allergy
• Pregnant women

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

Erlangen, 91052, Germany

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Food Intolerance

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Model Details: During confocal endomicroscopy food antigens are given on the duodenal mucosa. The response of the mucosa is evaluated by the entry of fluorescein into the intestinal lumen and cell shedding

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: September 24, 2021
• Study Start: May 1, 2021
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)