Updates

Areas of Research Food Allergies

The Texas Children’s Food Allergy Program is a division of the Department of Immunology, Allergy, and Rheumatology. The program is part of the FARE Clinical Network Centers of Excellence.

The mission of this program is to provide personalized, high-quality patient care and increased access to cutting-edge research, innovative treatment advances and quality patient support groups for infants, children and adolescents with food allergies.

The four goals of the program are as follows:

  1. Offer comprehensive patient centered experience for each child and family, with the most current treatment for food allergy disorders
  2. Provide access to state-of-the-art food desensitization protocols to accurately diagnose patients with food allergies and determine the best possible treatment options.
  3. Introduce new methods for the diagnosis and treatment of eosinophilic esophagitis.
  4. Extend educational research and outreach to prevent severe food allergy reactions in schools.

Research Studies Open to Enrollment

CEGIR DEGAS Study for Patients with Eosinophilic Gastritis (EG)

  • What is the purpose of this study?: The main reason for this research study is to determine the safety and effectiveness of a study drug called Dupilumab in adolescents and adults with eosinophilic gastritis (EG).
  • Who can participate? Children and adults ages ≥ 12 and < 71 years old years that have been diagnosed with EG. 
  • Who should I contact for more information?

Preventing Asthma in High Risk Kids (PARK) 

Randomized, double-blind, placebo controlled, parallel arm study with 96 week treatment phase using Omalizumab or placebo and 96 week observation phase

  • Study Sponsor: The National Institute of Allergy and Infectious Diseases (NIAID)
  • Eligibility: The child should be between 24-47 months of age with 2-4 episodes of wheezing in the past 12 months. At least one biological parent or sibling with history of asthma or allergy.
  • What is requested: Monthly injection of Omalizumab or placebo, nasal swabs, saliva, blood, skin testing, environmental samples, urine, and stool sample.

COVID19 Survey for Parents of Children with Food Allergy

  • Study Sponsor: Texas Children’s Hospital/Baylor College of Medicine
  • Eligibility: Male or female, 18 years or older and the parent of at least one child diagnosed with food allergy.
  • What is requested: Survey completion

Outcome Measures for Eosinophilic Gastrointestinal Disease across Ages (CEGIR OMEGA)

A Prospective, Multicenter Study to Compare and Validate Endoscopic, Histologic, Molecular and Patient-Reported Outcomes in Pediatric and Adult Patients with Eosinophilic Esophagitis (EoE), Gastritis (EG) and Colitis (EC)

  • Study Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
  • Eligibility: Male or female 3 years of age or greater diagnosed with EoE, EG or EC.
  • What is requested: Completion of questionnaires. Optional: a sample of tissue from your standard of care endoscopy and blood sample collection.

Regeneron Dupilumab EoE

A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis

  • Study Sponsor: Regeneron Pharmaceuticals
  • Eligibility: Male or Female 12 years of age or greater diagnosed with EoE as demonstrated by biopsy after 8 weeks of high dose PPI. Report of at least 4 episodes of dysphagia in the 2 weeks prior to baseline.
  • What is requested: Treatment with a shot of Dupilumab or Placebo, electronic diary completion, tissue sample from endoscopy procedure, and blood sample collection.

FARE patient registry

A registry for food-allergic individuals and their caregivers to quickly, conveniently and privately share their food allergy experiences through simple online surveys in order to help advance food allergy research.

  • Study Sponsor: Food Allergy Research and Education (FARE)
  • Eligibility: Male or female of all ages with food allergy
  • What is requested: Online survey completion

For more information, please contact foodallergynurse@texaschildrens.org or 832-824-3398

Upcoming Research Studies

EOE Kids

A randomized, 2-part double-blind, placebo-controlled study to investigate the efficacy and safety of Dupilumab in pediatric patients age 1 to <12 years with active eosinophilic esophagitis

  • Study Sponsor: Regeneron Pharmaceuticals
  • Expected start date: January 2021
  • Target enrollment: 3 patients
  • Eligibility: Male or female between the age of 1-12 years diagnosed with active eosinophilic esophagitis. History of symptoms to be a result of EOE such as abdominal pain, chest pain, acid reflux, food regurgitation, dysphagia, vomiting, or refusal to eat in the month prior to screening.
  • What is requested: Treatment with a shot of Dupilumab or Placebo, electronic diary completion, tissue sample from endoscopy procedure, and blood sample collection.

Dupilumab Eosinophilic Gastritis Study (CEGIR DEGAS)

A phase 2 randomized double-blind, placebo-controlled clinical trial to evaluate the efficacy of Dupilumab in subjects with eosinophilic gastritis

  • Study Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
  • Expected start date: January 2021
  • Target enrollment: 3 patients
  • Eligibility: Male or female age 12 years and up with active eosinophilic gastritis as demonstrated by biopsy with a peak gastric count of ≥30 eos/hpf in at least 5 hpfs in the gastric antrum and/or body. History by patient report of moderate to severe EG symptoms (stomach pain, stomach cramping, nausea, bloating, burning feeling in the chest, starting to eat and feeling full too quickly, loss of appetite, vomiting, or diarrhea at least 2 days per week in the 2 weeks prior to screening.
  • What is requested: Treatment with a shot of Dupilumab or Placebo, electronic diary completion, tissue sample from endoscopy procedure, and blood sample collection.

Systems Biology of Early Atopy (SUNBEAM)

This is a prospective cohort study in which pregnant women (at any stage of pregnancy), the offspring’s biological father, and the offspring will be enrolled and the offspring will be observed from birth to age 3 years.

  • Study Sponsor: The National Institute of Allergy and Infectious Diseases (NIAID)
  • Expected start date: January 2021
  • Target enrollment: 200 patients
  • Eligibility: Pregnant women age 18 years or older planning to give birth at the Texas Children’s Hospital Pavilion for Women who agree to enroll offspring into the study at birth.
  • What is requested: Clinical assessments will be conducted, questionnaire information collected, and biological and environmental samples collected on the mother, father, and child in the prenatal, perinatal, and postnatal periods of the child’s life.

For more information, please contact foodallergynurse@texaschildrens.org or 832-824-3398

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