The Effect of Sucralfate Slurry in Patients With Eosinophilic Esophagitis
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Eosinophilic Esophagitis
Intervention: Sucralfate (Drug); Intraluminal Impedance (Procedure); Intraluminal Impedance (Device)
Phase: Phase 0
Status: Recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): David Katzka, MD, Principal Investigator, Affiliation: Mayo Clinic
Overall contact: Debra M. Geno, CCRP, Phone: 507-538-0367, Email: geno.debra@mayo.edu
Summary
Could Sucralfate be a non-steriodal treatment option for patients with Eosinophilic
esophagitis?
Clinical Details
Official title: The Effect of Sucralfate Slurry on Dilated Intercellular Spaces, Tight Junctions, Mucosal Impedance and Mucosal Activity in Patients With Eosinophilic Esophagitis
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The Effectiveness of Sucralfate treatment in patient's with EoE
Secondary outcome: Measuring Mucosal impedance
Detailed description:
Eosinophilic esophagitis (EoE) is a Th2 type allergy mediated disease that is characterized
by dense esophageal eosinophilia in patients with chronic esophageal symptoms. One of
the mechanisms of eosinophilic esophagitis is exposure of food antigens to antigen
recognition cells in the esophageal mucosa that initiates a chronic allergy-based
inflammatory response [1, 2]. It is believed that this exposure is facilitated through
dilation of the intercellular spaces (DIS) between esophageal epithelial cells (termed
spongiosis). This is substantiated by several studies which have demonstrated that: first,
DIS is commonly found in biopsies from patients with active EoE and reverses with steroid
therapy [3]; second, DIS correlates to physiologic demonstration of increased esophageal
epithelial permeability as shown through transepithelial small molecule flux in mucosal
biopsies appraised in Ussing chambers [4], and third, DIS is associated with decreased
expression of specific epithelial tight junction proteins such as filaggrin [3]. Thus, a
suggested sequence of events in EoE that leads to allergen initiated inflammation includes
down regulation of tight junction proteins, dilation of intercellular spaces in the surface
epithelium followed by increased permeability and facilitated exposure to food antigens.
Of the present therapies available, topical steroids and in a subset of EoE patients, proton
pump inhibitors may improve epithelial permeability. Unfortunately, in the case of proton
pump inhibitors, there is early data suggesting that their therapeutic benefit is not
sustained. With the use of steroids, there are fears of what the long term side effects of
continued use of swallowed steroids might be. The other alternative treatment, diet
exclusion therapy is difficult to tailor to the patient and impractical for most adult
patients. As a result, alternative treatments are need for EoE.
Sucralfate is a medication that was developed for the treatment of acid-peptic diseases.
It's mechanism of action in healing lesions such as gastroduodenal mucosal ulceration still
remains unclear but has been described as a "cytoprotective" agent. Several mechanisms have
been suggested to be responsible for this protection. These include: binding to and
protection of exposed eroded areas, increased prostaglandin production, improved vascular
flow, and increased mucus production. This compound has also been shown to augment
potential difference in gastric mucosa suggesting a decreased in ion flow. The
investigators have shown in measuring mucosal impedance in EoE, this may be related to
closure of intercellular spaces which could make this an attractive therapy for eosinophilic
esophagitis. Furthermore, the side effect profile of sucralfate is excellent with little
systemic absorption. Sucralfate is a category (B) medication, safe for females of child
bearing years.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
• 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.
Exclusion criteria:
- 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
Locations and Contacts
Debra M. Geno, CCRP, Phone: 507-538-0367, Email: geno.debra@mayo.edu
Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States; Recruiting Debra M. Geno, CCRP, Phone: 507-538-0367, Email: geno.debra@mayo.edu Lori A. Kryzer, Phone: 507-538-2403, Email: kryzer.lori@mayo.edu
Additional Information
Starting date: January 2015
Last updated: August 17, 2015
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