Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients

Food Allergy Clinical Trial

Official title: A Phase II Trial to Evaluate the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients

Status Recruiting

Clinical Trial Summary

This is a phase II randomized double-blind placebo-controlled trial that aims at evaluating the safety and tolerability of oral encapsulated fecal microbial transplantation therapy (MTT) in peanut allergic patients. In this research the investigators would like to learn more about ways to treat peanut allergies. The primary objective is to evaluate whether MTT with antibiotic pretreatment can increase the threshold of peanut reactivity during a double-blind placebo-controlled food challenge from <=100 mg peanut protein to 300 mg after 28 days of MTT /placebo therapy and 4 months post therapy initiation.

Clinical Trial Description

This is a phase II randomized double-blind placebo-controlled trial that aims at evaluating the safety and tolerability of oral encapsulated fecal microbial transplantation therapy (MTT) in 24 peanut allergic patients, 12-17 years of age. After reacting to <=100 mg peanut protein during initial DBPCFC, patients will be randomized to receive either oral Vancomycin and Neomycin or placebo/placebo for 7 days. Patients will then come to the Experimental and Therapeutic Unit (ETU) to receive orally 5 capsules of MTT or placebo under medical supervision. Patients will then take 2 capsules of MTT or placebo daily for 27 days. Patients will return to the ETU to undergo a second DBPCFC within 2 weeks of end of MTT/placebo treatment and 4 months post MTT initiation. They will return to the ETU for an exit visit 6 months after end of treatment. Gut microbiota will be analyzed serially using state-of-the-art 16SRNA sequencing prior to transplantation, then at 4 weeks, 4-month, and 6 months post transplantation. Immunological biomarkers and mechanistic studies will be performed on blood taken at baseline, second DBPCFC visit and exit visit. Adverse events will be monitored carefully throughout the study. ;

Related Conditions & MeSH terms

• Anaphylaxis
• Food Allergy
• Food Allergy Peanut
• Food Hypersensitivity
• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

• NCT number: NCT05695261
• Study type: Interventional
• Source: Boston Children's Hospital
• Contact: Angela Zhang
• Phone: 617-919-1566
• Email: Angela.Zhang@childrens.harvard.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: June 8, 2023
• Completion date: March 1, 2027