Eosinophilic EsophagitisEarly Phase 1EoENCT02353078
The Effect of Sucralfate Slurry in Patients With Eosinophilic Esophagitis
A Early Phase 1 study testing Sucralfate and Intraluminal Impedance in people with Eosinophilic Esophagitis, run by Mayo Clinic at 1 site in United States.
Trial summary
Could Sucralfate be a non-steriodal treatment option for patients with Eosinophilic esophagitis? Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Sucralfate and Intraluminal Impedance
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Effect of Sucralfate Slurry on Dilated Intercellular Spaces, Tight Junctions, Mucosal Impedance and Mucosal Activity in Patients With Eosinophilic Esophagitis
Could Sucralfate be a non-steriodal treatment option for patients with Eosinophilic esophagitis?
Read the 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.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Sucralfate, Intraluminal Impedance
- Keywords
- Eosinophilic Esophagitis (EOE)
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucralfateDrug
Also called Carafate
Sucralfate slurry 1 gram four times daily for four weeks
Intraluminal ImpedanceProcedure or surgery
Also called Mucosal 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.
Intraluminal ImpedanceDevice
Also called Mucosal 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Intraluminal Impedance; Device: Intraluminal Impedance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
Measuring Mucosal impedance
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Katzka, Mayo Clinic
- Investigators
- David Katzka, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353078
- Sponsor's protocol ID
- 14-008661
- Acronym
- EoE
- Status last verified
- Oct 2017
- First submitted
- 26 Jan 2015
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sucralfate Slurry on Dilated Intercellular Spaces, Tight Junctions, Mucosal Impedance and Mucosal Activity in Patients With Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT02353078
- Acronym / sponsor ID
- EoE / 14-008661
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic Esophagitis (EOE)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucralfate | Experimental | Drug: SucralfateThis 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. |
| Intraluminal Impedance | Experimental | Procedure: Intraluminal Impedance, Device: Intraluminal ImpedanceThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SucralfateAlso: CarafateSucralfate slurry 1 gram four times daily for four weeks | Drug | Sucralfate |
| Intraluminal ImpedanceAlso: Mucosal ImpedanceDuring 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. | Procedure or surgery | Intraluminal Impedance |
| Intraluminal ImpedanceAlso: Mucosal ImpedanceThe 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. | Device | Intraluminal Impedance |
Primary outcome
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.
1 secondary outcome
Measuring Mucosal impedance
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Katzka, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sucralfate and Intraluminal Impedance in people with Eosinophilic Esophagitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effectiveness of Sucralfate treatment in patient's with EoE (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.