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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-antibiotics Arm | Experimental | The first 10 patients will not receive antibiotics prior to receiving the investigational agent, which consists of screened-donor inoculum of a biologically active human substance (FMT). We will give oral frozen FMT over 2 days. |
|
| Antibiotics Arm | Experimental | An additional 5 patients will receive antibiotics prior to receiving the investigational agent, which consists of screened-donor inoculum of a biologically active human substance (FMT). We will give oral frozen FMT over 2 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Capsule | Biological | We will treat patients with oral encapsulated frozen FMT over 2 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of FMT-related adverse events grade 2 or above | Presence of FMT-related adverse events grade 2 or above | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rima Rachid, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33463542 | Derived | Berin MC. Dysbiosis in food allergy and implications for microbial therapeutics. J Clin Invest. 2021 Jan 19;131(2):e144994. doi: 10.1172/JCI144994. |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| 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 | 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. | 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 | 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 | 12 months |