Tolerability of Goat Milk Protein in Eosinophilic Esophagitis Patients With Cow Milk Protein Trigger

Study Purpose

Eosinophilic esophagitis (EoE) is a chronic immune mediated disease characterized by eosinophilic infiltration in esophageal epithelium and resulting in esophageal dysfunction. While the exact pathogenesis is yet to be elucidated, EoE is considered an atopic disease. This classification is in part due to the inflammatory infiltrate of eosinophils, basophils and T-cells producing Th2 cytokines, yet it may also be triggered by environmental allergens. In addition, the rates of atopy are approximately 3 times higher in patients with EoE than in the general population. Furthermore, and most convincing, EoE is successfully managed with dietary exclusion of triggering groups in both pediatric and adult patients, further confirming the atopic nature of the disease. The most frequent dietary trigger for EoE is milk, but there is limited data on the cross-reactivity of milk from other species. Guidelines addressing the diagnosis and treatment of EoE in both children and adults have not addressed the use of non-bovine milk in patients with cow's milk triggered EoE. Restrictive diets are often challenging for patients and contribute to a reduced quality of life. Our own, anecdotal experience in two patients with milk triggered EoE who requested to introduce goat's milk into the patients' diet were that reintroduction did not trigger a clinical or histological flare of EoE. These cases of successful introduction of non-bovine milk introduces the possibility that a milk-free diet need not necessarily be exclusive of all species. The aim of this study is to assess tolerability and safety of goat's milk in patients with EoE in whom cow's milk has been confirmed to be a trigger food for their disease.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
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.	Interventional
Eligible Ages	N/A - 18 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- All patients diagnosed with EoE age ≤ 17.5 years at inclusion who were confirmed to have cow's milk as a trigger by demonstrating improvement during elimination and histologic relapse following reintroduction.

- Verified histologic remission on milk-free diet on endoscopy prior to intervention.

- Proton-pump inhibitors may be used if treatment is maintained at the same dose from the screening endoscopy throughout the trial period, and was used at the time that milk was demonstrated to be the triggering food.

- Ability to consent to enrollment in the trial - legal guardians with joint consent for patients >10 years.

Exclusion Criteria:

- Patients with clinical IgE-mediated milk allergy.

- Provisional exclusion: patients without a known IgE-mediated allergic reaction to milk who have a positive RAST (as per local reference range) or positive skin-prick test for cow milk or goat milk must be assessed by a certified allergist/immunologist and cleared for the trial by a supervised goat milk challenge.

- Use of inhaled corticosteroids for more than 5 days per month during the trial period.

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.	NCT05180578
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.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shaare Zedek Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Israel
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis

Additional Details

This prospective, multi-center trial will include patients with EoE diagnosed according to the accepted definitions: symptoms of esophageal dysfunction and >15 Eos/HPF on an esophageal biopsy, who were confirmed to have cow's milk as a trigger by demonstrating improvement during elimination and histologic relapse following reintroduction. Following full informed consent of the patient / guardians, patients will be offered to join the trial to assess their tolerance to goat milk. Due to the theoretical risk of developing IgE-mediated allergy on prolonged food protein type restriction, RAST-testing or skin-prick testing to cow milk will be undertaken to exclude IgE-mediated sensitization prior to introduction of goat milk. In patients with positive results, candidates can elect to withdraw from the study or alternatively an allergist will be consulted to consider the appropriateness of a medically observed goat milk challenge. Strict compliance with milk-free diet will be re-enforced for not less than 6 weeks prior to the patient's closest routine follow-up endoscopy. Baseline symptom profile will be recorded. Baseline endoscopy with routine biopsies (defined below) will be performed as part of the routine scheduled follow-up endoscopy as recommended by guidelines, in order to confirm histologic remission of EoE. Patients with baseline esophageal inflammation will be excluded from the study. Patients in histologic remission will be commenced on goat milk containing diet with not less than 1 daily serving. Repeat symptom profile assessed at 6 weeks and at 12 weeks, with repeat endoscopy with routine biopsies at 12±2 weeks. If symptoms recur prior to 12 weeks, endoscopy may be moved up earlier, from 6 weeks onwards. Patients in clinical and histologic remission at 12 weeks will be followed until week 52 with repeat scheduled endoscopy. Goat milk consumption will be permitted during the follow-up, but not be required daily as in the first time period. A goat milk consumption diary will be collected over the 4 weeks prior to this endoscopy.

Arms & Interventions

Arms

Experimental: Tolerability of goat milk consumption in patients with EOE triggered by milk allergy

Elimination of cow milk from diet . Goat milk containing diet.

Interventions

Other: - Goat milk diet

Elimination of cow milk from diet . Goat milk containing diet.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shaare Zedek, Jerusalem, Israel

Status

Recruiting

Address

Shaare Zedek

Jerusalem, , 91031

Site Contact

[email protected]

+972-2-6666743

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