Endomicroscopy, IBS and Food Intolerance

Food Intolerance Clinical Trial

Official title:

Confocal Endomicrosopy for the Detection of Food Intolerance in Patients With Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692613
• Other study ID #: A139/12
• Status: Completed
• Phase: N/A
• First received: September 20, 2012
• Last updated: June 2, 2015
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: June 2015
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Background:

The immediate endoscopic identification and diagnosis of intraepithelial structures and immediate and delayed reactions to allergens in the mucosal surface of the gut are unmet goals in the diagnosis and management of subjects with food intolerances, who are negative to all available tests. Endomicroscopy may be helpful to further visualize and characterize unmasked small bowel reactions to foods, which has not been described before.

Confocal laser endomicroscopy provides confocal microscopic imaging simultaneously to the macroscopic view ,which enables the examiner to see immediate reactions after exposure and it further allows capturing of fluid excreted by the gut for further analysis to understand the pathology behind this reaction further.

N=50 patients with unexplained bloating and diarrhoea with suspicion of food intolerance and negative testing with routine methods. Patients with Lactose intolerance n=10 patients to compare results. Patients with Fructose intolerance n=10 patients to compare results. Volunteers with Barrett's esophagus who need evaluation for possible dysplasia in the Barrett's mucosa with confocal endomicrosopy but no symptoms of bloating and abdominal pain (n=10) to serve as healthy controls for allergy testing.

Methods:

The primary objective is to investigate whether endomicroscopy will allow the detection of an allergic reaction of the gut after exposure of the 5 major allergens in the following way:

After standard gastroscopy with the endomicroscope including evaluation of the surface of the upper gastrointestinal tract, i.v. injection of Fluorescein, then initial visualisation of the duodenal surface including count of initial lymphocytes/mononuclear cells in the lamina propria: Allergen 1 (milk), allergen 2 (wheat), allergen 3 (soya),allergen 4 (apple), allergen 5 (yeast).

The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in the lamina propria of the duodenum, representing an acute reaction to one of the allergens sprayed to its surface through the endoscope channel.

Description:

The primary endpoint is the visible marked increase of lymphocytes and mononuclear cells in the lamina propria of the duodenum, representing an acute reaction to one of the allergens sprayed to its surface through the endoscope channel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age > 18 years

• ongoing abdominal symptoms such as bloating and abdominal pain

• negative routine testing for food intolerance (or known lactose/fructose intolerance)

• written informed consent

Exclusion Criteria:

• no consent

• known reason for the abdominal pain and bloating other than lactose/fructose intolerance

• M. Whipple

• known infectious gastrointestinal disease

• stricture in the upper gastrointestinal tract

• age >18years

• impaired renal function (Creatinine >1.2 mg/dL)

• pregnancy or breast feeding

• inability to obtain informed consent

• active GI Bleeding

• known allergy to Methylene blue or Fluorescein

• participation in other clinical trials within the last 4 weeks

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endomicroscopy
• Food Intolerance
• Inflammatory Bowel Syndrome

Locations

Country	Name	City	State
Germany	University Hospital Schleswig Holstein, Campus Kiel, Unit Experimental Endoscopy	Kiel

Sponsors (3)

Lead Sponsor	Collaborator
University of Schleswig-Holstein	Great Ormond Street Hospital for Children NHS Foundation Trust, Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of mucosal reaction		immediate	No