A Phase II Trial to Evaluate the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients
This is a phase II 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 for Part A 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. The primary objective for Part B is to evaluate whether MTT with antibiotic pretreatment can lead to sustained unresponsiveness (SU) defined as tolerating the same dose of peanut protein administered during a food challenge at baseline and 12 weeks after OIT cessation.
‣ Male and female young adults aged 12-17 years, who meet all the following inclusion criteria, will be enrolled in the study.
• Develop dose limiting symptoms to peanut during a DPBCFC conducted in accordance with PRACTALL (Practical Issues in Allergology, Joint United States/European Union Initiative) guidelines at 1 mg, 3 mg, 10 mg, 30 mg, or 100 mg peanut protein (Part A only).
• Has a positive SPT to peanut (≥3mm) and/or a positive peanut-specific IgE \>0.35kU/L (Part A only).
• For asthmatic patients, has a Spirometry or Peak Flow with Measurement of FEV1\>=80% of predicted
• Has a negative urine hCG test if a female participant.
• Agrees to use an acceptable single-barrier form of birth control from enrollment through the exit DBPCFC study visit if female of childbearing potential and sexually active. An example of a single-barrier method of contraception includes condoms or oral contraceptives. Acceptable methods of birth control include implants, injectables, combined oral contraceptives, some intrauterine contraceptive devises (IUDs), sexual abstinence, a vasectomized partner, the contraceptive patch, the contraceptive ring, and condoms.
• Able to swallow 2 empty capsules size 00.
• Able to give informed assent and guardian willing to give informed consent.
• Willing and able to participate in the study requirements, including study visits, food challenges, serial stool collection
• Willing to undergo telephone or email follow-up to assess for safety and adverse events.
⁃ Subject has been on maintenance peanut oral immunotherapy for at least a year (part B only).