Eosinophilic Esophagitis Clinical Therapy Comparison Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 3 - 17 |
| Updated: | 7/21/2018 |
| Start Date: | July 9, 2013 |
| End Date: | March 2019 |
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."
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."
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).
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).
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.
We found this trial at
1
site
6621 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Carla M. Davis, MD
Phone: 832-824-1319
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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