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Evaluating the Safety and Efficacy of Fecal Microbiota Transplant in Peanut Allergic Patients
This is a Phase I trial to evaluate the safety and efficacy of 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.
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|Eligible Ages||18 Years - 40 Years|
Inclusion Criteria:1. Allergic reaction during food challenge at 3 mg
- - 100 mg peanut protein.
Exclusion Criteria:1. History of severe anaphylaxis. 2. Required more than one dose of epinephrine to treat allergic reaction. 3. Other food allergies excluding peanut and tree nuts. 4. Patients with gelatin allergy 5. Chronic illness other than controlled asthma, mild eczema, allergic rhinitis. 6. Infections necessitating frequent systemic antibiotics. 7. History of chronic immunosuppressive therapies. 8. History of other chronic diseases, except for atopic conditions. 9. More than one episode of allergic or non-allergic urticaria within a 2 month span of time, or history consistent with poorly controlled persistent asthma. 10. Previous participation in a peanut immunotherapy protocol or on aeroallergen immunotherapy maintenance therapy for less than 6 months or who received Omalizumab therapy over the past year. 11. Women who are pregnant or breast feeding, or planning to get pregnant during the time of the study. 12. Sexually active female patients who refuse to use contraception for study. 13. GI conditions including inflammatory bowel disease eosinophilic esophagitis, food protein induced enterocolitis, reflux, constipation, esophageal dysmotility, swallowing dysfunction, delayed gastric emptying syndromes, pill esophagitis or history of aspiration pneumonia within 3 months prior to screening. 14. History of rheumatologic conditions. 15. Direct relative with inflammatory bowel disease. 16. Patients with any form of immunodeficiency. 17. Patients participating or planning to participate in the next year, or have participated within the prior year in other interventional trials in which investigational drug therapy was administered. 18. Positive for Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus. 19. Systemic antibiotic therapy over the past 6 months or systemic corticosteroids therapy over the past 3 months. 20. Allergic reaction during food challenge at 1 mg peanut protein.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
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The person who is responsible for the scientific and technical direction of the entire clinical study.
|Rima Rachid, MD|
|Principal Investigator Affiliation||Boston Children’s Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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 FMT in patients with peanut allergy aged 18-40 years. A total of 10 patients with peanut allergy will be enrolled after they fail a screening food challenge to peanut. Participating will be given oral encapsulated frozen FMT over 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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