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.
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.
Patients with a history of severe anaphylaxis to any food (hypotension requiring vasopressor support, hypoxia requiring mechanical ventilation, or neurological compromise)
For Part A, patients with current diagnosis of an IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk, provided that MTT does not contain traces of these food estimated to be above the LOAEL in 5 capsules combined, and excluding oral allergy syndrome, and excluding other foods that the MTT donor avoided)
For Part B, patients with current diagnosis of an IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk, provided that MTT does not contain traces of tree nuts, egg and milk estimated to be above the LOAEL in 4 capsules, and excluding oral allergy syndrome, excluding the food that the patient is undergoing immunotherapy to, and excluding other foods that the MTT donor avoided).
Patients with chronic illness other than controlled asthma that is mild intermittent, mild- persistent or moderate persistent, mild eczema and allergic rhinitis. Exceptions can be made per PI discretion if illness is not expected to affect allergies or treatment.
Parallel
Microbial Transplantation Therapy
Biological/VaccineParticipants randomized to the MTT/antibiotic arm of PART A will be administered oral MTT capsules over the course of 28 days. Participant enrolled on PART B will be administered oral MTT capsules over the course of 28 days.
Antibiotic
DrugParticipants randomized to the MTT/antibiotic arm of PART A will receive oral antibiotics for 7 days prior to the MTT administration visit. Participant enrolled on PART B will receive oral antibiotics for 7 days prior to the MTT administration visit.
Placebo (in place of MTT)
Other interventionParticipants randomized to the placebo arm of PART A will be administered oral placebo capsules in place of MTT over the course of 28 days.
Placebo (in place of antibiotics)
Other interventionParticipants randomized to the placebo arm of PART A will receive oral placebo in place of antibiotics for 7 days prior to the MTT administration visit.
Oral Immunotherapy (OIT)
Other interventionParticipant enrolled on PART B will be on maintenance peanut oral immunotherapy (OIT) for their clinical care.
PART A: Changes in threshold of peanut reactivity during DBPCFC (<=100 mg to 300 mg peanut protein)
PART A: Changes in threshold of peanut reactivity during DBPCFC after 28 days of MTT from \<=100 mg to 300 mg peanut protein and 4 months post therapy initiation.
PART B: Achievement of sustained unresponsiveness after 12 weeks of MTT
PART B: Achievement of sustained unresponsiveness after 12 weeks of MTT therapy combined with peanut OIT followed by 12 weeks therapy cessation
PART A: Changes in threshold of peanut reactivity during DBPCFC (<=100 mg to 600 mg peanut protein)
PART A: Changes in threshold of peanut reactivity during DBPCFC after 28 days of MTT from \<=100 mg to 600 mg peanut protein and 4 months post therapy initiation.
PART A & B: Adverse Events
PART A \& B: MTT Treatment emergent adverse events
PART A & B: Changes in Skin Test Wheal Size and IgE level
PART A \& B: Changes in skin test peanut specific wheal size, peanut-specific IgE level over time
PART A & B: Changes in Gut Microbial Composition
PART A \& B: Changes in gut microbial composition and persistence of that change over time
Click on the lead sponsor to view all of their trials.
Rima Rachid
Lead sponsor
Boston Children's Hospital
Sponsor institution
University of Minnesota
Collaborator
