Confocal Laser Endomicroscopy, IBS and Stress

NCT02316132 | Withdrawn

• 1 other identifier: IBS stress
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

After standard endomicroscopy with fluorescein to investigate for dysplasia in Barrett's esophagus the endoscope will be forwarded into the 2nd part of the duodenum. Fluorescein is needed for CLE but is not part of the investigation. Initial CLE baseline images will be taken to assure intact mucosa and allow later detailed baseline counts of intraepithelial lymphocytes (IEL) and epithelial breaks in the duodenal mucosa. Thereafter, either 10 ml NaCl 0.9% or 100µg CRF topped up to 10ml with NaCL 0.9% (according to randomisation) will be injected intravenously. Endoscopist and assistant staff will be blinded to the randomisation. Subsequently, the gut surface will be examined for at least 5 min with endomicroscopy for any change in IEL, epithelial breaks/gaps with extrusion of fluorescein into the gut lumen and widening of intervillous space. Post procedure mucosal fluid will be aspirated for assessment of mast cell tryptase and eosin catatonic protein (ECP), and 8 duodenal biopsies will be taken for 1) electron microscopy to visualise mast cell degranulation and 2) paraffin embedding for subsequent staining for mast cell tryptase to identify mast cell activation and numbers. The procedure will take around 15 minutes in addition to the routine investigation performed prior to the study. A study outline is presented in figure 1. Samples taken are the same amount as done in the previous food associated study.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• visible marked increase of leaks/gaps with extrusion of fluorescein into the gut lumen.

  immediate

Study Arms (2)

Stress

ACTIVE COMPARATOR

Injection of corticotropin releasing factor

Drug: Stress

Control

PLACEBO COMPARATOR

Injection of 0.9% saline 10 ml

Drug: Control

Interventions

Stress DRUG

Corticotropin-Releasing Hormone

Also known as: CRH

Stress

Control DRUG

Saline 0.9%

Also known as: Saline

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• No abdominal symptoms such as bloating and abdominal pain
• Barrett's esophagus
• Independent indication for confocal laser endomicroscopy for evaluation of Barrett's dysplasia
• Written informed consent for participation in this study

You may not qualify if:

• Any known other gastrointestinal disease including infection such as helicobacter pylori, Morbus Whipple or others, celiac disease, or chronic inflammatory bowel disease
• Active or recent GI Bleeding
• Stricture in the upper gastrointestinal tract
• Impaired renal function (Creatinine \>1.2 mg/dL)
• Pregnancy or breast feeding
• Inability to obtain informed consent
• Known allergy to Methylene blue or Fluorescein
• Participation in other clinical trials within the last 4 weeks

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Annette Fritscher-Ravens, MD, PhD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

• Mark Ellrichmann, MD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Unit of Experimental Endoscopy

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 12, 2014
• Study Start: December 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 6, 2022

Record last verified: 2022-06

Locations

DE (1)