Eosinophilic Esophagitis Clinical Therapy Comparison Trial

Study Purpose

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: 1. 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 2. 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."

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	3 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion: 1. Signed written informed consent and assent if applicable prior to performing any study specific procedure. 2. Male or female subjects aged 3-17 years old. 3. 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). 4. Subjects who have failed at least a two month trial of proton pump inhibitor. 5. 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. 6. Positive allergy testing on prick and/or patch testing. Exclusion Criteria 1. Subjects who are responsive to at least a two month trial of a proton pump inhibitor. 2. Diagnosis of Inflammatory Bowel Disease or static encephalopathy. 3. Prior abdominal surgery and other organ disorder not including atopic diseases. 4. Previous esophageal surgical procedure. 5. Previous esophageal congenital disorders such as tracheal esophageal fistula and esophageal atresia. 6. Positive for pregnancy. 7. Previous therapy within 6 weeks with oral or swallowed steroids or strict dietary elimination of major allergens 8. Presence of increased eosinophils in the stomach, small intestine, large intestine, and colon based on Debrosse et al.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01821898
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Baylor College of Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Carla M. Davis, MD
Principal Investigator Affiliation	Baylor College of Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis

Additional Details

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).

Arms & Interventions

Arms

Active Comparator: Positive for food allergy: Group A

Oral Budesonide

Active Comparator: Positive for food allergy: Group B

Elimination diet

Interventions

Drug: - Oral Budesonide

This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day

Other: - Elimination diet

This group will receive an elimination diet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Texas Children's Hospital, Houston, Texas

Status

Address

Texas Children's Hospital

Houston, Texas, 77030

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