Eosinophilic Esophagitis
Conditions
Keywords
EOE
Brief summary
This study is being done to see if the investigators can use only the cytosponge ( A 10 minute, in office procedure that does not require sedation) to replace the 6-10 endoscopies routinely perform during dietary restriction and food reintroduction in EoE?
Detailed description
Dietary Therapy has been shown to be successful in the treatment of adult and pediatric patients with eosinophilic esophagitis Dietary studies were initially reported in children, but the results appear to be similar in adult patients. Elemental diets are successful in 70-95% of patients but are poorly tolerated. A six food elimination diet has been effective in about 70% of adult patients with EoE . In these adult studies skin prick testing was not helpful in predicting which foods would lead to a flare of disease when reintroduced into the diet. Therefore, the current standard of care requires multiple EGDs with esophageal biopsy during the dietary restriction and reintroduction phases of this study. Since the investigators are making lifelong dietary decisions during this process of food reintroduction, it is imperative the investigators be accurate. Unfortunately, these multiple EGDs have significant cost and are invasive procedures with some risk. Moreover, there is significant indirect costs with travel and time off work for the patients and drivers. Previous studies have found the esophageal sponge to be an accurate technique of accessing esophageal eosinophilia in EoE . The sponge is swallowed as a 12 mm capsule on a string. The capsule rapidly dissolves upon entering the stomach and the sponge then expands and can be pulled out the mouth five minutes after ingestion. In previous studies, the procedure was very well tolerated and all patients preferred the sponge to endoscopy. Therefore the sponge is a well tolerated, inexpensive, very low risk procedure that would be an ideal option to replace EGD esophageal sampling in the evaluation of dietary treatment of EoE.
Interventions
DEVICECytosponge
A capsule with a string attached with a sponge inside is swallowed. The string is held without any tension to allow the capsule to move into the stomach. The string will be held for five minutes to allow the capsule to dissolve in the stomach; a round mesh sponge about the size of a quarter is released.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Eosinophilic Esophagitis \> than 15 Eos phf and failed to respond to the PPI therapy * Going through the six food elimination diet or have just completed elimination the six foods: fish, nuts, eggs, soy, wheat, and milk
Exclusion criteria
* Clinical evidence of infectious process potentially contributing to dysphagia ( candidiasis, CMV, herpes) * Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm) * Esophageal minimal diameter \< 13 mm on structured barium esophagram
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histological Remission by Sponge Cytology | approximately 4 weeks post food reintroduction | Number of subject's sponge cytology to accurately detect histological remission when compared with standard of care EGD (defined as a peak eosinophil count of \<15 eos/hpf on endoscopic biopsy) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eosinophilic Esophagitis Activity Index Patient Reported Outcomes (EEsAI PRO) Score | approximately 4 weeks post food reintroduction | The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). A PRO \< 20 defines asymptomatic EoE |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cytosponge-directed Food Reintroduction Subjects will follow the six-food elimination diet per clinical protocol. The cytosponge will be used to monitor the diet at certain timepoints during food reintroduction.
Cytosponge: A capsule with a string attached with a sponge inside is swallowed. The string is held without any tension to allow the capsule to move into the stomach. The string will be held for five minutes to allow the capsule to dissolve in the stomach; a round mesh sponge about the size of a quarter is released | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Cytosponge-directed Food Reintroduction | — |
|---|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 10.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 22 participants | — |
| Sex: Female, Male Female | 12 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Histological Remission by Sponge Cytology
Number of subject's sponge cytology to accurately detect histological remission when compared with standard of care EGD (defined as a peak eosinophil count of \<15 eos/hpf on endoscopic biopsy)
Time frame: approximately 4 weeks post food reintroduction
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cytosponge-directed Food Reintroduction | Histological Remission by Sponge Cytology | 13 Participants |
Secondary
Eosinophilic Esophagitis Activity Index Patient Reported Outcomes (EEsAI PRO) Score
The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). A PRO \< 20 defines asymptomatic EoE
Time frame: approximately 4 weeks post food reintroduction
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cytosponge-directed Food Reintroduction | Eosinophilic Esophagitis Activity Index Patient Reported Outcomes (EEsAI PRO) Score | 16.5 score on a scale |