Eosinophilic EsophagitisPhase 2NCT01821898
Eosinophilic Esophagitis Clinical Therapy Comparison Trial
A Phase 2 study testing Oral Budesonide and Elimination diet in people with Eosinophilic Esophagitis, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Eosinophilic Esophagitis (EoE) is a disorder in which a type of white blood cell (eosinophil) involved in allergic reactions, enter and cover the walls of the esophagus (food pipe). As a result, the esophagus becomes swollen and blocked making it difficult to swallow, and this leads to heartburn. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Oral Budesonide and Elimination diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2013to 24 Sep 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed written informed consent and assent if applicable prior to performing any study specific procedure.
- Male or female subjects aged 3-17 years old.
- Diagnosis of EoE within 2 months of enrollment (greater than or equal to 15 eosinophils per high powered field in both proximal or distal esophageal specimens).
- Subjects who have failed at least a two month trial of proton pump inhibitor.
- A female subject of childbearing potential who is or may become sexually active agrees to routinely use contraception from the time of signing informed consent and assent until 30 days from end of study.
- Positive allergy testing on prick and/or patch testing.
Who cannot join
- Subjects who are responsive to at least a two month trial of a proton pump inhibitor.
- Diagnosis of Inflammatory Bowel Disease or static encephalopathy.
- Prior abdominal surgery and other organ disorder not including atopic diseases.
- Previous esophageal surgical procedure.
- Previous esophageal congenital disorders such as tracheal esophageal fistula and esophageal atresia.
- Positive for pregnancy.
- Previous therapy within 6 weeks with oral or swallowed steroids or strict dietary elimination of major allergens
- Presence of increased eosinophils in the stomach, small intestine, large intestine, and colon based on Debrosse et al.
Trial locations and contacts
1 site in 1 country.
About this study
Eosinophilic Esophagitis (EoE) is a disorder in which a type of white blood cell (eosinophil) involved in allergic reactions, enter and cover the walls of the esophagus (food pipe). As a result, the esophagus becomes swollen and blocked making it difficult to swallow, and this leads to heartburn. In severe cases it can lead to food getting stuck in the esophagus and poor growth or weight loss in children
The main purpose of this research study is to compare the effectiveness of two different types of treatment for EoE:
Read more
- Oral viscous budesonide- which is a steroid medication that has been used to treat asthma. Recently, it has been used as a therapy to treat the eosinophilic inflammation in EoE, and
- Specific food elimination.
The study will also be looking to see if a blood test is useful in following the progression of EoE. Currently the only way to follow EoE is by repeating endoscopy, which is a more "invasive test."
Read the detailed description
This study is a open label, randomized, prospective clinical trial comparing the efficacy of a topical steroid preparation to an antigen (food) elimination diet.
A total of 40 participants will be recruited for this study that are positive for food allergens. Study participants will be randomly assigned to treatments as described below, and the duration of each treatment phase will be 16 weeks.
The subjects will be randomized to group A and B. Subject and study team will NOT be blinded to the group assignments.
Group A will receive oral viscous budesonide at a dose of 1 or 2 mg daily depending on the height.
Group B will receive an elimination diet (elimination of the foods the subject is allergic to).
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Oral Budesonide, Elimination diet
- Keywords
- Eosinophil, Reflux, Esophagus, Food allergy, Trouble Swallowing, Pediatrics
- Medical subject headings
- Eosinophilic Esophagitis, Gastroesophageal Reflux, Food Hypersensitivity, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral BudesonideDrug
Also called Steroid
This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day
Elimination dietOther
This group will receive an elimination diet
| Study group | Role | What they receive |
|---|---|---|
| Positive for food allergy: Group A | Active comparator | Oral Budesonide Receives: Drug: Oral Budesonide |
| Positive for food allergy: Group B | Active comparator | Elimination diet Receives: Other: Elimination diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Number of Eosinophils/High Powered Field
The primary outcome will be the peak eosinophil/high powered field on repeat biopsy after the treatment phase.
Measured: 16 weeks
Secondary outcomes (3)
Quality of Life Survey Score
PedsQL total survey score to assess overall quality of life before and after treatment
Measured: 16 weeks
Symptom Score
Assess the subject's symptoms using the validated tool termed Pediatric Eosinophilic Esophagitis (EoE) Symptom Severity Module by measuring % of normal bolus transit swallow and % of normal peristaltic esophageal body contractions.
Measured: 16 weeks
Exploratory Studies
Proteomic studies search for certain proteins in the blood that may be linked to active EoE. Immune analysis will help identify better methods for diagnosis, treatment, and prevention of immune system changes leading to diseases.
Measured: Conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study start9 Jul 2013
- Primary completion24 Sep 2018
- Study completion24 Sep 2018
Why it stopped: Recruitment was below expectation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla McGuire Davis, Baylor College of Medicine
- Investigators
- Carla M. Davis, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821898
- Sponsor's protocol ID
- H-27999
- Other IDs
- 36533
- Status last verified
- Dec 2020
- First submitted
- 27 Mar 2013
- Last updated
- 11 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eosinophilic Esophagitis Clinical Therapy Comparison Trial
- ClinicalTrials.gov ID
- NCT01821898
- Acronym / sponsor ID
- H-27999
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophil, Reflux, Esophagus, Food allergy, Trouble Swallowing, Pediatrics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was below expectation
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 9 Jul 2013 (actual)
- Primary completion
- 24 Sep 2018 (actual)
- Study completion
- 24 Sep 2018 (actual)
- First posted
- 1 Apr 2013 (estimated)
- Results
- Posted 11 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eosinophilic Esophagitis (EoE) is a disorder in which a type of white blood cell (eosinophil) involved in allergic reactions, enter and cover the walls of the esophagus (food pipe). As a result, the esophagus becomes swollen and blocked making it difficult to swallow, and this leads to heartburn. In severe cases it can lead to food getting stuck in the esophagus and poor growth or weight loss in children
The main purpose of this research study is to compare the effectiveness of two different types of treatment for EoE:
- Oral viscous budesonide- which is a steroid medication that has been used to treat asthma. Recently, it has been used as a therapy to treat the eosinophilic inflammation in EoE, and
- Specific food elimination.
The study will also be looking to see if a blood test is useful in following the progression of EoE. Currently the only way to follow EoE is by repeating endoscopy, which is a more "invasive test."
Detailed description
This study is a open label, randomized, prospective clinical trial comparing the efficacy of a topical steroid preparation to an antigen (food) elimination diet.
A total of 40 participants will be recruited for this study that are positive for food allergens. Study participants will be randomly assigned to treatments as described below, and the duration of each treatment phase will be 16 weeks.
The subjects will be randomized to group A and B. Subject and study team will NOT be blinded to the group assignments.
Group A will receive oral viscous budesonide at a dose of 1 or 2 mg daily depending on the height.
Group B will receive an elimination diet (elimination of the foods the subject is allergic to).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive for food allergy: Group A | Active comparator | Drug: Oral BudesonideOral Budesonide |
| Positive for food allergy: Group B | Active comparator | Other: Elimination dietElimination diet |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Signed written informed consent and assent if applicable prior to performing any study specific procedure.
- Male or female subjects aged 3-17 years old.
- Diagnosis of EoE within 2 months of enrollment (greater than or equal to 15 eosinophils per high powered field in both proximal or distal esophageal specimens).
- Subjects who have failed at least a two month trial of proton pump inhibitor.
- A female subject of childbearing potential who is or may become sexually active agrees to routinely use contraception from the time of signing informed consent and assent until 30 days from end of study.
Key exclusion criteria (8 listed)
- Subjects who are responsive to at least a two month trial of a proton pump inhibitor.
- Diagnosis of Inflammatory Bowel Disease or static encephalopathy.
- Prior abdominal surgery and other organ disorder not including atopic diseases.
- Previous esophageal surgical procedure.
- Previous esophageal congenital disorders such as tracheal esophageal fistula and esophageal atresia.
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 |
|---|---|---|
| Oral BudesonideAlso: SteroidThis group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day | Drug | Positive for food allergy: Group A |
| Elimination dietThis group will receive an elimination diet | Other | Positive for food allergy: Group B |
Primary outcome
Peak Number of Eosinophils/High Powered Field
Time frame: 16 weeks
The primary outcome will be the peak eosinophil/high powered field on repeat biopsy after the treatment phase.
3 secondary outcomes
Quality of Life Survey Score
Time frame: 16 weeks
Symptom Score
Time frame: 16 weeks
Exploratory Studies
Time frame: Conclusion of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Eosinophilic Esophagitis
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruiting
Patient-Centered Decision Support for Eosinophilic Esophagitis
Eosinophilic Esophagitis
Active, not recruitingPhase 2
A Study in Adult Participants With EoE to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 20 mg Up to 24 Weeks
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
RecruitingPhase 2
A Trial of Upadacitinib for Non-responsive Eosinophilic Esophagitis
EoE, Eosinophilic Esophagitis
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.
Carla M. Davis, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Budesonide and Elimination diet in people with Eosinophilic Esophagitis, run by Baylor College of Medicine 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 11 Jan 2021. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peak Number of Eosinophils/High Powered Field (time frame: 16 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 Jan 2021.