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Evaluating the Safety and Efficacy of Oral Encapsulated Fecal Microbiota Transplant in Peanut Allergic Patients
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.
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|Eligible Ages||18 Years - 40 Years|
Inclusion Criteria:1. Develop dose limiting symptoms to peanut during a DPBCFC conducted in accordance with PRACTALL guidelines at 3 mg, 10 mg, 30 mg, or 100 mg peanut protein. 2. Have a positive SPT to peanut (≥5mm) and/or a positive peanut-specific IgE >0.35kU/L. 3. Have a Spirometry or Peak Flow with Measurement of FEV1>=80% of predicted 4. Have negative test results for Hepatitis B (HBV), Hepatitis C (HCV), and Human Immunodeficiency Virus (HIV). 5. Have a negative urine hCG test if a female participant. 6. Agrees to use an acceptable single-barrier form of birth control from enrollment through the 4 month DBPCFC study visit if female of childbearing potential if 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. 7. Able to swallow 2 empty capsules size 00. 8. Able to give informed consent. 9. Willing and able to participate in the study requirements, including study visits, DBPCFCs, serial stool collection 10. Willing to undergo telephone follow-up to assess for safety and adverse events.
Exclusion Criteria:1. Patients with a history of severe anaphylaxis to peanut and/or tree nuts (hypotension requiring vasopressor support, hypoxia requiring mechanical ventilation, or neurological compromise and/or ICU admission) 2. Patients who required more than one dose of epinephrine to treat previous allergic reaction to peanut and/or tree nuts. 3. Patients with other food allergies (i.e. IgE mediated food restrictions) excluding peanut and tree nuts. 4. Patients with gelatin allergy. 5. 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. 6. Recurrent or chronic infections necessitating frequent systemic (including oral) antibiotic administration. 7. History of chronic immunosuppressive therapies. 8. More than two episodes of idiopathic urticaria within a 2 month span of time prior to screening, or history consistent with poorly controlled persistent asthma. 9. 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. 10. Women who are pregnant or breast feeding, or planning to get pregnant during the time of the study. 11. Sexually active female patients who refuse to use contraception from enrollment through the 4 month DBPCFC study visit 12. Patient with GI conditions including inflammatory bowel disease eosinophilic esophagitis, food protein induced enterocolitis, uncontrolled reflux despite medication, uncontrolled chronic constipation despite medication, esophageal dysmotility, swallowing dysfunction, delayed gastric emptying syndromes, pill esophagitis or history of aspiration pneumonia within 3 months prior to screening. 13. Patient with current or a history of rheumatologic conditions. 14. Patients who have a direct relative (biologic parent or sibling) with inflammatory bowel disease. 15. Patients with any form of immunodeficiency. 16. Patients participating or planning to participate in the next 6 months, or have participated within the prior year in other interventional trials in which investigational drug therapy was administered. 17. Patients with positive antibody test results for HBV, HCV, or HIV. 18. Patients who have received systemic antibiotic therapy over the past 6 weeks or systemic corticosteroids therapy for 1 week or more over the past 3 months. 19. Patients who develop dose limiting symptoms to peanut during a DPBCFC conducted in accordance with PRACTALL guidelines 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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
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 encapsulated 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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