The Effect of Sucralfate Slurry in Patients With Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Early Phase 1

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

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.
    

Intervention name(s): Sucralfate; Intraluminal Impedance; Intraluminal Impedance
Intervention type(s): Drug; Procedure; Device
Intervention description(s): Sucralfate slurry 1 gram four times daily for four weeks; 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.; 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 intervention name(s): Carafate; Mucosal Impedance; Mucosal Impedance
Intervention MeSH terms: Sucralfate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eosinophilic Esophagitis (EOE)