The Effect of Sucralfate Slurry in Patients With Eosinophilic Esophagitis

NCT02353078 | Completed Early Phase 1

• 1 other identifier: 14-008661
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Could Sucralfate be a non-steriodal treatment option for patients with Eosinophilic esophagitis?

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic Esophagitis (EOE)

Outcome Measures

Primary Outcomes (1)

• The Effectiveness of Sucralfate treatment in patient's with EoE

  • The effect treatment is defined by 50%, 3 of the 6 patients having less \< 15 eosinophilia per high power field by in the pathology at the time of follow up endoscopic biopsies.

  4 weeks

Secondary Outcomes (1)

• Measuring Mucosal impedance

  4 weeks

Study Arms (2)

Sucralfate

EXPERIMENTAL

This is a pilot study in which 6 patients with active EoE defined by consensus criteria (ref) who have undergone recent endoscopy will be administered sucralfate slurry 1 gram four times daily for four weeks following which repeat endoscopy with esophageal biopsies will be performed. Patients will be those who had not had medical treatment for EoE or those who have not responded to proton pump inhibitors.

Drug: Sucralfate

Intraluminal Impedance

EXPERIMENTAL

This procedure involves passing a mucosal impedance probe through the endoscope and gently placing the tip of the probe on the esophageal mucosa. Measurements will be made at 2,5,10 and 15 cm above the gastroesophageal junction. There is no increased risk to the procedure and it adds approximately 2 minutes to the procedure.

Procedure: Intraluminal Impedance; Device: Intraluminal Impedance

Interventions

Sucralfate DRUG

Sucralfate slurry 1 gram four times daily for four weeks

Also known as: Carafate

Sucralfate

Intraluminal Impedance PROCEDURE

During the initial endoscopy, esophageal mucosal impedance will also be measured. This procedure involves passing a mucosal impedance probe through the endoscope and gently placing the tip of the probe on the esophageal mucosa. Measurements will be made at 2,5,10 and 15 cm above the gastroesophageal junction. There is no increased risk to the procedure and it adds approximately 2 minutes to the procedure.

Also known as: Mucosal Impedance

Intraluminal Impedance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors.

You may not qualify if:

• Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy
• Pregnant and lactating females will be excluded
• Diabetic patients will be excluded as episodes of hyperglycemia have been reported
• Patient with chronic renal failure/on dialysis will be excluded
• Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
• Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Sucralfate

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thioglycosides; Sulfur Compounds; Organic Chemicals; Sucrose; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• David Katzka, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David A. Katzka, MD

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 2, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 11, 2017

Record last verified: 2017-10

Locations

US (1)