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PPIREoE Study: An International Collaborative Study

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What is the Research Study About?

EoE therapeutic guidelines now support Proton Pump Inhibitor (PPI) medications as a therapy for eosinophilic esophagitis (EoE). Unfortunately, individual response to PPIs for treatment of EoE is highly variable (15-70%). Because of this, research to identify which patients may respond to PPI therapy has become increasingly important. We have developed a pioneering, internationally recognized team of translational researchers in the field of Proton Pump Inhibitor Responsive Eosinophilic Esophagitis (PPIREE) to identify the factors that contribute to individual variability in response. We are investigating how specific genetic variations affect the way children metabolize proton pump inhibitors and how this associates with health outcomes and side effects such as increased rates of infection.

How Can Genetics Influence Response to PPI Therapy for EoE?

People who carry the gene for an enzyme that has enhanced activity for metabolizing PPIs (EM) are more likely to fail PPI therapy for EoE than normal metabolizers (NM) (Figure 1A). Genetic variants in the signaling pathway responsible for recruiting eosinophils to the esophagus in EoE, can also influence response to PPI for EoE (Figure 1B). Individuals who carry signaling pathway variants that associate with increased recruitment of eosinophils to the esophagus in EoE are more likely to fail to respond to PPI for EoE.

Figure 1A: Conventional Dosing of PPI for GERD with watermark - Ed Mougey
Figure 1A: Conventional Dosing of PPI for GERD
Figure 1B: LTR Study with watermark - Ed Mougey
Figure 1B: LTR Study

Study Design

With your / your child's consent, we will collect a saliva sample from your child to obtain genomic DNA for genotyping variants in CYP2C19 and STAT6 genes, among others. We will also collect samples of the bacteria that live on and inside your child. We will then look for associations between CYP2C19 / STAT6 genotypes, bacteria profiles, and phenotypes that we obtain from your child's medical history. This data is important because it will help us to identify factors that influence response to PPI therapy for EoE.

  • Study Type Prospective Observational (Research Study)
  • Estimated Enrollment 500 participants
  • Primary Purpose Outcomes Analysis
  • Official Title Metagenomic Analysis of Microflora in Children
  • Estimated Study Completion Date December 31, 2025
  • Study Start Date Pending
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teenage girl with glasses smiling with a thumbs up

Research Study Participant Eligibility Criteria

If you are between the ages of 2-18 years old, have been diagnosed with Eosinophilic Esophagitis, have been prescribed a proton pump inhibitor and meet the following criteria:

  • Have not taken antibiotics, systemic steroids, antifungals, antivirals, antiparasitics, immunosuppressants or cytokines in the last 6 months
  • Have not taken swallowed steroids (e.g. budesonide) in the last 8 weeks
  • Have not had esophageal surgery
  • Do not have Inflammatory Bowel Disease, Celiac Disease, or another gastrointestinal disorder.
  • Have access to the internet and phone service
  • Are currently under the care of a pediatric gastroenterologist

Our EoE Team is Ready

My background is that I was trained in general pediatrics and pediatric gastroenterology at the Children’s Hospital of Philadelphia. I am currently in sunny Orlando, Florida at Nemours Children’s Hospital and serve as the Division Chief for the Division of Gastroenterology, Hepatology and Nutrition. I have had the privilege to care for patients with EoE for over 12 years.

Our team has been fortunate to bring many advances to the field of pediatric EoE with over 60 peer reviewed publications. A focus on children, teens and families has always been at top of mind, with the development of the first and only patient/family validated outcome metrics called the PedsQLEoE module and the Pediatric Eosinophilic Esophagitis (EoE) Score (PEES™ v2.0).

Our PPIREoE Study will advance our knowledge about the factors, both environmental and genetic, that contribute to individual variability in response to proton pump inhibitor therapy for the treatment of eosinophilic esophagitis. This knowledge will allow our physicians to recommend treatment options that are individually personalized, to improve response and reduce the need for additional endoscopy procedures.

James P. Franciosi Signature

James P. Franciosi M.D., M.S., M.S.C.E., F.A.A.P.
Chief, Division of Gastroenterology, Hepatology and Nutrition

Help advance our research to improve our treatments

If you are interested in participating in our research study, call us or click the link below to email our study team member.

Contact Us