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San Raffaele EoE Biobank
Eosinophilic Esophagitis (EoE) is a immuno-mediated disease, characterised by a Th-2 food-antigen driven chronic inflammatory response of the esophagus. Main symptoms are dysphagia and food bolus impaction, frequently overlapping with most atypical and general symptoms like heartburn or regurgitation and difficulty to thrive in children. Overall incidence and prevalence of EoE are rapidly increasing. The complete comprehension of pathogenetic and molecular mechanism underlying this complex and relatively new disease is still to be conquered. For this reason, we created this EoE Biobank, in order to collect blood, oral and esophageal tissue samples of proven EoE patients to...
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Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients with Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
The study is to assess the safety of neffy or IM Adrenalin in patients who are experiencing allergic reactions after an OFC, allergen Immunotherapy (AIT), or other allergy challenge that may require epinephrine intervention.
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Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants
This is a Phase 1/2 study to evaluate the safety and clinical activity of ENP-501 in non-peanut allergic (NPA) healthy participants and participants with an established peanut allergy (PA)
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Subconjunctival Humira for Boston Keratoprosthesis
This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery.
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Sustained Unresponsiveness (SU) to Cashew Nut Protein Following Oral Allergen-Specific Immunotherapy
This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy of Cashew Nut Protein Immunotherapy: A Protocol of a Single-Center Randomized Controlled Trial in the Pediatric Population", NCT06328504. At the end of the original RCT all participants will undergo an open Oral Food Challenge (OFC) to assess desensitization after 3 months on the maintenance dose of OIT. Patients who have completed the first part of the study will be invited to the current part of the project: - First arm (initial experimental group) - patients will continue oral immunotherapy (OIT) with cashew nut protein (1200mg) for the next 8 months (+/- 3...
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Sustained Unresponsiveness (SU) to Sesame Protein Following Low-dose Oral Allergen-specific Immunotherapy
This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy and Safety of Low-Dose Sesame Oral Immunotherapy in Pediatric Patients", NCT06261554. At the end of the original RCT all participants will undergo an open Oral Food Challenge (OFC) to assess desensitization after 3 months on the maintenance dose of OIT. Patients who have completed the first part of the study will be invited to the current part of the project: - First arm (initial experimental group) - patients will continue oral immunotherapy (OIT) with low dose of sesame protein (300mg) for the next 8 months (+/- 3 weeks). - Second arm (initial control group -...
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Trans-Cervical and Trans-abdominal Ultrasound for Monitoring Esophageal Thickness in Eosinophilic Esophagitis
Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease characterized by eosinophilic infiltration of the esophageal mucosa, leading to symptoms of dysphagia and food impaction. Currently, upper endoscopy with biopsy is the gold standard for diagnosis and disease monitoring, but it is invasive, costly, and associated with procedural risks. The investigators want to use ultrasound imaging as a non-invasive assessment of esophageal wall thickness as a surrogate marker for mucosal inflammation. Participants will undergo ultrasound assessment at the same day of endoscopy, and than after 3-6 months (optional). The correlation between US-measured esophageal thickness...
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Umbilical Cord Blood Therapy in a Child With Eosinophilic Duodenitis and Autism Spectrum Disorder: a Case Study
This single-case exploratory clinical study aims to evaluate the therapeutic potential of umbilical cord blood (UCB) infusion in a pediatric patient diagnosed with both eosinophilic duodenitis (ED) and autism spectrum disorder (ASD). ED is a rare inflammatory gastrointestinal condition characterized by excessive eosinophil infiltration in the duodenal mucosa, often associated with immune hypersensitivity and allergic responses. ASD is a neurodevelopmental disorder marked by deficits in social interaction, communication, and behavioral flexibility. Recent evidence suggests a link between gastrointestinal inflammation and neurodevelopmental symptoms via the gut-brain axis,...
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UNC Cashew Sublingual Immunotherapy
The CASCADES study will investigate the safety and efficacy of sublingual immunotherapy (SLIT) for the treatment of cashew allergy in children ages 1-11 years old. Primary efficacy will be assessed after 18 months of cashew SLIT. Lab studies and an oral food challenge after 6 months of cashew SLIT will help determine how quickly cashew SLIT begins to take effect.
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Validation Of A Parent Administered Symptom Score For Unsettled Infants (Every Baby is UnIQue)
It's common for infants to be unsettled, especially in the first few months of life. While this is often normal, persistent symptoms can be stressful for families. Parents naturally seek explanations, and common suspected causes include colic, reflux, eczema, and cow's milk allergy (CMA). However, CMA is frequently over diagnosed, which can lead to unnecessary changes such as stopping breastfeeding or switching to expensive specialist formulas. To address this, we've developed an online questionnaire to help track and understand symptoms in unsettled infants. Our long-term goal is to use this tool to support more accurate diagnosis of CMA. Before that, we need to test and...
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