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Trial record 12 of 141 for:    "eosinophilic esophagitis"

The Effect of Sucralfate Slurry in Patients With Eosinophilic Esophagitis (EoE)

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ClinicalTrials.gov Identifier: NCT02353078
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: Sucralfate Procedure: Intraluminal Impedance Device: Intraluminal Impedance Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Sucralfate Slurry on Dilated Intercellular Spaces, Tight Junctions, Mucosal Impedance and Mucosal Activity in Patients With Eosinophilic Esophagitis
Study Start Date : January 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sucralfate

Arm Intervention/treatment
Experimental: Sucralfate
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
Sucralfate slurry 1 gram four times daily for four weeks
Other Name: Carafate

Experimental: Intraluminal Impedance
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
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.
Other Name: Mucosal Impedance

Device: Intraluminal Impedance
The mucosal impedance probe is a 2.13 mm catheter (tiny tube), called an Intraluminal Impedance, will be passed through the channel of the standard endoscope. There is no increased risk to the procedure and it adds approximately 2 minutes to the procedure.
Other Name: Mucosal Impedance




Primary Outcome Measures :
  1. The Effectiveness of Sucralfate treatment in patient's with EoE [ Time Frame: 4 weeks ]
    • 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.


Secondary Outcome Measures :
  1. Measuring Mucosal impedance [ Time Frame: 4 weeks ]
    Mucosal impedance reflects the ability of electric current to flow between two sensors while in contact with the epithelium. An increase in current flow is presumably due to an increase in ions and water crossing the membrane, which are good conductors of electricity. Through this technique an overall measure of "leakiness" of the esophageal epithelium is obtained. This increased permeability may reflect epithelial destruction as in erosive esophagitis and Eosinophilic esophagitis. The investigators will measure the mucosal impedance at the baseline during the upper endoscopy and at the follow up endoscopy. Comparing these measurement to the eosinophilic count on pathology at baseline and followup.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353078


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: David Katzka, MD Mayo Clinic

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Responsible Party: David A. Katzka, David A. Katzka, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02353078     History of Changes
Other Study ID Numbers: 14-008661
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by David A. Katzka, Mayo Clinic:
Eosinophilic Esophagitis (EOE)

Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Sucralfate
Anti-Ulcer Agents
Gastrointestinal Agents