Evaluating the Safety and Efficacy of Oral Encapsulated Fecal Microbiota Transplant in Peanut All… (NCT02960074) | Clinical Trial Compass
CompletedPhase 1
Evaluating the Safety and Efficacy of Oral Encapsulated Fecal Microbiota Transplant in Peanut Allergic Patients
United States15 participantsStarted 2017-03-03
Plain-language summary
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.
Who can participate
Age range18 Years – 40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 3 mg, 10 mg, 30 mg, or 100 mg peanut protein.
✓. Has a positive SPT to peanut (≥5mm) and/or a positive peanut-specific IgE \>0.35kU/L.
✓. Has a Spirometry or Peak Flow with Measurement of FEV1\>=80% of predicted
✓. Have negative test results for Hepatitis B surface antigen and antibodies (HBV), Hepatitis C (HCV), and Human Immunodeficiency Virus (HIV).
✓. Have a negative urine hCG test if a female participant.
✓. 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.
✓. Able to swallow 2 empty capsules size 00.
✓. Able to give informed consent.
Exclusion criteria
✕. Patients with a history of severe anaphylaxis to peanut and/or treenuts (hypotension requiring vasopressor support, hypoxia requiring mechanical ventilation, or neurological compromise and/or ICU admission)
What they're measuring
1
Presence of FMT-related adverse events grade 2 or above
. Patients with other food allergies (i.e. IgE mediated food restrictions not including oral allergy syndrome) excluding peanut and tree nuts.
✕. Patients with Bovine gelatin allergy.
✕. 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.
✕. History of chronic immunosuppressive therapies.
✕. Patients who are diagnosed with active, chronic urticaria.
✕. Patients who have received a dose of peanut oral immunotherapy within the last year, Patients on aeroallergen immunotherapy maintenance therapy for less than 6 months, or patients who have received Omalizumab therapy within the last year.