Eosinophilic Esophagitis Clinical Therapy Comparison Trial

NCT01821898 | Terminated Phase 2 Results

• 2 other identifiers: H-2799936533
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 2.Specific food elimination.

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophil; Reflux; Esophagus; Food allergy; Trouble Swallowing; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Secondary Outcomes (3)

• Quality of Life Survey Score

  16 weeks

• Symptom Score

  16 weeks

• Exploratory Studies

  Conclusion of study

Study Arms (2)

Positive for food allergy: Group A

ACTIVE COMPARATOR

Oral Budesonide

Drug: Oral Budesonide

Positive for food allergy: Group B

ACTIVE COMPARATOR

Elimination diet

Other: Elimination diet

Interventions

Oral Budesonide DRUG

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

Also known as: Steroid

Positive for food allergy: Group A

Elimination diet OTHER

This group will receive an elimination diet

Positive for food allergy: Group B

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis; Gastroesophageal Reflux; Food Hypersensitivity; Deglutition Disorders

Interventions

Budesonide; Steroids; Elimination Diets

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Esophageal Motility Disorders; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

The trial was terminated due to the inability of current subjects to complete the protocol and poor enrollment.

Results Point of Contact

• Title: Carla M. Davis, MD
• Organization: Baylor College of Medicine/Texas Children's Hospital

carlad@bcm.edu

832-824-1319

Study Officials

• Carla M. Davis, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 1, 2013
• Study Start: July 9, 2013
• Primary Completion: September 24, 2018
• Study Completion: September 24, 2018
• Last Updated: January 11, 2021
• Results First Posted: January 11, 2021

Record last verified: 2020-12

Locations

US (1)