Clinical Trials Logo

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05180578
Study type Interventional
Source Shaare Zedek Medical Center
Contact Oren Ledder, Dr.
Phone +972-2-6666743
Email [email protected]
Status Recruiting
Phase N/A
Start date November 12, 2020
Completion date March 2024

See also
  Status Clinical Trial Phase
Completed NCT03382678 - CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry
Recruiting NCT05083312 - Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial Phase 3
Recruiting NCT04593251 - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis Phase 1
Active, not recruiting NCT03633617 - Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE) Phase 3
Recruiting NCT04543409 - A Study of Benralizumab in Patients With Eosinophilic Esophagitis Phase 3
Recruiting NCT04941742 - The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
Terminated NCT02314455 - Esophageal Absorption in EoE N/A
Completed NCT01953575 - Mucosal Impedance and Eosinophilic Esophagitis N/A
Completed NCT01386112 - Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis Phase 1/Phase 2
Recruiting NCT04991935 - Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis Phase 3
Recruiting NCT04149470 - Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE) Phase 4
Recruiting NCT04416217 - Eosinophilic Esophagitis Steroid Safety Study
Completed NCT02579876 - Milk Patch for Eosinophilic Esophagitis Phase 2
Recruiting NCT02331849 - Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry. N/A
Active, not recruiting NCT02202590 - Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus N/A
Active, not recruiting NCT05176249 - Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population
Completed NCT00961233 - Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE) N/A
Terminated NCT01404832 - The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors Phase 4
Completed NCT00266578 - A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders Phase 3
Recruiting NCT03781596 - EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone Phase 4