This is a Phase I trial to evaluate the safety and efficacy of oral encapsulated fecal microbiota transplantation (FMT) in the treatment of peanut allergy. In this research the investigators would like to learn more about ways to treat peanut allergies. There is currently no known cure for peanut allergy. The primary aim is to assess safety and tolerability of oral FMT in patients with peanut allergy aged 18-40 years.
This is a study of fecal microbiota transplantation (FMT) in the treatment of peanut allergy. The primary aim is to assess safety and tolerability of oral encapsulated FMT in patients with peanut allergy aged 18-40 years. A total of 15 patients with peanut allergy will be enrolled after they fail a screening food challenge to peanut. 10 patients will be given oral encapsulated frozen FMT over 1-2 days. 5 additional patients will receive antibiotics prior to being given oral encapsulated frozen FMT over 1-2 days. Patients will undergo a second and third food challenge after receiving FMT. The expected duration of the study for each subject will be one year. Stool collection, skin testing and blood samples will be done serially.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
We will treat patients with oral encapsulated frozen FMT over 2 days.
Boston Children's Hospital
Boston, Massachusetts, United States
Presence of FMT-related adverse events grade 2 or above
Presence of FMT-related adverse events grade 2 or above
Time frame: 12 months
Changes in threshold of peanut reactivity during a double blind placebo controlled food challenge from 100 mg to 300 mg peanut protein, using PRACTALL guidelines
To evaluate whether FMT therapy alone or after antibiotic pretreatment can increase the threshold of peanut sensitivity during a double blind placebo controlled food challenge from 100 mg peanut protein to 300 mg.
Time frame: 1 day
Changes in threshold of peanut reactivity from 100 mg to 600 mg peanut protein during double blind placebo controlled food challenge using PRACTALL guidelines
To evaluate whether FMT therapy alone or after antibiotic pretreatment can increase the threshold of peanut sensitivity during a double blind placebo controlled food challenge from 100 mg peanut protein to 600 mg
Time frame: 1 day
Changes in skin test peanut specific wheal size in mm
To evaluate the changes following FMT (with and without antibiotics), to peanut specific skin prick test.
Time frame: 12 months
Changes in serum peanut-specific IgE level in kU/L
To evaluate the changes following FMT (with and without antibiotics), to serum peanut-specific IgE level in kU/L
Time frame: 12 months
Changes in gut microbial composition measured in serial stool samples, using 16S RNA sequencing and persistence of that change over time
To evaluate the changes following FMT (with and without antibiotics), to gut microbial composition measured in serial stool samples, using 16S RNA sequencing and persistence of that change over time
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Time frame: 12 months