Cow's Milk Elimination for Treatment of Eosinophilic Esophagitis

Study Purpose

The investigators seek to assess the efficacy of removing cow's milk from an EoE patient's diet. This will be determined by esophageal inflammation and clinical and histological response to the milk elimination treatment.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
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.	Observational [Patient Registry]
Eligible Ages	1 Year - 18 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients aged 1-18.

- Patients who meet the criteria for diagnosis of EoE with ≥15 eosinophils per high power field and who had been previously treated with an adequate dose of PPI for 6-8 weeks or had a normal 24 hour ph probe study will be recruited from the patients seen by one of the physicians in the EoE clinic at Lurie Children's and other participating centers.

- Patients who agree to cow's milk elimination diet as their treatment of EoE.

Exclusion Criteria:

- Patients who started on oral or swallowed steroids (prior use of steroids that was discontinued more than two months prior to enrollment does not constitute an exclusion criterion) - Patients who are unable to tolerate the cow's milk elimination diet.

- Patients with concurrent eosinophilic gastroenteritis or eosinophilic colitis

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.	NCT05083156
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.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Joshua Wechsler, MD
Principal Investigator Affiliation	Ann & Robert H Lurie Children's Hospital of Chicago
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

The dietary approach is based on the hypothesis that food antigen(s) trigger eosinophilic inflammation and clinical and histological remission can be induced by identifying and excluding the causative food antigen(s). It is believed that eliminating causative food antigen(s) target the cause and thus induces long term remission. This process is difficult as it requires multiple, invasive endoscopies and introduces the possibility of iatrogenic effects such as nutrient deficiency due to simultaneous multiple food eliminations. In addition, patient compliance may be compromised, both intentionally and unintentionally as many families report the elimination process to be both confusing and frustrating. This prospective study eliminating only cow's milk proteins, which are a common cause of esophageal inflammation in patients with eosinophilic esophagitis, will assess the histological response in a cohort of children receiving care at Lurie Children's.

Contact a Trial Team

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Chicago, Illinois

Status

Address

Ann & Robert H Lurie Childjren's Hospital of Chicago

Chicago, Illinois, 60611

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