Trial Outcomes & Findings for Cytosponge and Dietary Therapy in EoE (NCT NCT02599558)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

approximately 4 weeks post food reintroduction

Results posted on

2022-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cytosponge-directed Food Reintroduction n=22 Participants 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
Age, Continuous	40 years STANDARD_DEVIATION 10.9 • n=22 Participants
Sex: Female, Male Female	12 Participants n=22 Participants
Sex: Female, Male Male	10 Participants n=22 Participants
Region of Enrollment United States	22 participants n=22 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Cytosponge-directed Food Reintroduction n=22 Participants 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.
Histological Remission by Sponge Cytology	13 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Cytosponge-directed Food Reintroduction n=22 Participants 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.
Eosinophilic Esophagitis Activity Index Patient Reported Outcomes (EEsAI PRO) Score	16.5 score on a scale Interval 9.0 to 28.8

Adverse Events

Cytosponge-directed Food Reintroduction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey A. Alexander, M.D.

Mayo Clinic

Phone: 507+284-0474

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place