Short Duration 6Fed Sponge For EoE Patients

Not Applicable

Withdrawn

• Conditions: Eosinophilic Esophagitis
• Interventions: Device: Cytosponge; Other: Diet; Other: EEsAI Pro; Other: Likert Scoring Scale

• Registration Number: NCT03354221
• Lead Sponsor: Mayo Clinic

Brief Summary

This research is being done to see if the investigators can use the cytosponge or esophacap (depending on availability) to determine if shorter duration SFED (two weeks versus six weeks) would have equal results.

Detailed Description

Dietary therapy has been shown to be successful in the treatment of adult and pediatric patients with eosinophilic esophagitis (EoE). 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.

The six food elimination diet (SFED) involves the elimination of the six most common food allergens (i.e. milk, wheat, soy, eggs, nuts, and fish) for six weeks and has become the mainstay of dietary therapy in EoE. A six week SFED has demonstrated excellent efficacy and durability in both pediatric and adult EoE. However, compliance with the SFED for a total of six weeks can be challenging for patients.

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.

Although initially described as a six week trial, it is possible that a shorter duration food elimination diet of 2 or 4 weeks would have equal efficacy. This would have important implications for patients as it would make the diet more tolerable.

Study Timeline

• Study Start: 2017-08
• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-27
• Primary Completion: 2018-12
• Study Completion: 2019-03-15
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cytosponge, Diet, EEsAI Pro, Likert Scoring Scale	Cytosponge	Patients going through the six food elimination diet (clinically) for EoE will be asked to participate. During the initial 6 week elimination period, participants will return at 2, 4 and 6 weeks to swallow the cytosponge. The cytosponge is a 10 minute procedure done in the office. This will be sent for histology, \<15 phf would be considered a responder. Results of the histology will help the investigator to direct the future of the 6 food elimination diet to determine if a period of 6 weeks of initial elimination is necessary. The EEsAI Pro questionnaire measures symptomatic response to the elimination of the foods. The Likert Scoring Scale measures patient experience of the cytosponge and the upper endoscopy.
Cytosponge, Diet, EEsAI Pro, Likert Scoring Scale	EEsAI Pro	Patients going through the six food elimination diet (clinically) for EoE will be asked to participate. During the initial 6 week elimination period, participants will return at 2, 4 and 6 weeks to swallow the cytosponge. The cytosponge is a 10 minute procedure done in the office. This will be sent for histology, \<15 phf would be considered a responder. Results of the histology will help the investigator to direct the future of the 6 food elimination diet to determine if a period of 6 weeks of initial elimination is necessary. The EEsAI Pro questionnaire measures symptomatic response to the elimination of the foods. The Likert Scoring Scale measures patient experience of the cytosponge and the upper endoscopy.
Cytosponge, Diet, EEsAI Pro, Likert Scoring Scale	Likert Scoring Scale	Patients going through the six food elimination diet (clinically) for EoE will be asked to participate. During the initial 6 week elimination period, participants will return at 2, 4 and 6 weeks to swallow the cytosponge. The cytosponge is a 10 minute procedure done in the office. This will be sent for histology, \<15 phf would be considered a responder. Results of the histology will help the investigator to direct the future of the 6 food elimination diet to determine if a period of 6 weeks of initial elimination is necessary. The EEsAI Pro questionnaire measures symptomatic response to the elimination of the foods. The Likert Scoring Scale measures patient experience of the cytosponge and the upper endoscopy.
Cytosponge, Diet, EEsAI Pro, Likert Scoring Scale	Diet	Patients going through the six food elimination diet (clinically) for EoE will be asked to participate. During the initial 6 week elimination period, participants will return at 2, 4 and 6 weeks to swallow the cytosponge. The cytosponge is a 10 minute procedure done in the office. This will be sent for histology, \<15 phf would be considered a responder. Results of the histology will help the investigator to direct the future of the 6 food elimination diet to determine if a period of 6 weeks of initial elimination is necessary. The EEsAI Pro questionnaire measures symptomatic response to the elimination of the foods. The Likert Scoring Scale measures patient experience of the cytosponge and the upper endoscopy.

Primary Outcome Measures

Name	Time	Method
Cytosponge pathology: number of Eosinophils directing dietary therapy	2 years	Patients will swallow the cytosponge at 2 weeks, 4 weeks and 6 weeks into the initial period of the 6 food elimination diet. Eosinophils \<15 phf will be considered histologic remission to dietary therapy. This response will be compared to the 6 week visit sponge eosinophilic histology.

Secondary Outcome Measures

Name	Time	Method
Eosinophilic Esophgitis Activity Index Pro (EEsAI Pro)	2 years	The EEsAI Pro uses the VDQ is visual dysphagia question AMS is avoidance, modification, slow eating question. Thes two along with questions on frequency of, duration of, pain associated with dysphagia make up the PRO (patient reported outcomes). The PRO is a number (0-100) calculated from the answer to the questions. A PRO\<20 defines asymptomatic EoE.
The tolerability of esophageal sponge compared to upper endoscopy with biopsy.	6 weeks	Patients return at the end of the 6 weeks initial elimination of the diet will complete the modified Likert scoring scale. This scale rates participant experience of the cytosponge versus the upper endoscopy. This is a short questionnaire for patients to compare their experiences swallowing the cytosponge versus completing an upper endoscopy. The scale is rated from "worst experience" to "best experience."

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States