Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients

Launched by RIMA RACHID · Jan 13, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to treat peanut allergies using a method called oral encapsulated microbiota transplantation therapy (MTT). The goal is to see if this treatment can help peanut allergy patients tolerate larger amounts of peanut protein, which could be life-changing for those who are typically very sensitive to peanuts. The study will compare the effects of the MTT with a placebo (a substance with no active ingredients) over a 28-day period, followed by monitoring for an additional four months.

To participate in the trial, individuals must be between the ages of 4 and 17 and have a history of allergic reactions to peanuts, confirmed by specific tests. They should also be able to swallow capsules and agree to follow study requirements. Unfortunately, those with a history of severe allergic reactions or certain medical conditions will not be eligible. Participants will take part in regular visits, including food challenges to test their peanut tolerance, and they will be monitored for any side effects during the study. This trial is a significant step towards finding new treatments for peanut allergies.

Gender

ALL

Eligibility criteria

• • The study will enroll 24 peanut allergic patients aged 12-17 who meet the eligibility criteria in Part A and 13 subjects aged 12-17 years who meet eligibility criteria in Part B.
• Inclusion Criteria:
• • Male and female young adults aged 12-17 years, who meet all the following inclusion criteria, will be enrolled in the study.
• • 1. 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 1 mg, 3 mg, 10 mg, 30 mg, or 100 mg peanut protein (Part A only).
• • 2. Has a positive SPT to peanut (≥3mm) and/or a positive peanut-specific IgE \>0.35kU/L (Part A only).
• • 3. For asthmatic patients, has a Spirometry or Peak Flow with Measurement of FEV1\>=80% of predicted
• • 4. Has a negative urine hCG test if a female participant.
• • 5. Agrees to use an acceptable single-barrier form of birth control from enrollment through the exit DBPCFC study visit if female of childbearing potential and 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.
• • 6. Able to swallow 2 empty capsules size 00.
• • 7. Able to give informed assent and guardian willing to give informed consent.
• • 8. Willing and able to participate in the study requirements, including study visits, food challenges, serial stool collection
• • 9. Willing to undergo telephone or email follow-up to assess for safety and adverse events.
• • 10. Subject has been on maintenance peanut oral immunotherapy for at least a year (part B only).
• Exclusion Criteria:
• • Subjects who fall into any of the following exclusion criteria at the time of screening are not eligible for enrollment into the study.
• • 1. Patients with a history of severe anaphylaxis to any food (hypotension requiring vasopressor support, hypoxia requiring mechanical ventilation, or neurological compromise)
• • 2. For Part A, patients with current diagnosis of an IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk, provided that MTT does not contain traces of these food estimated to be above the LOAEL in 5 capsules combined, and excluding oral allergy syndrome, and excluding other foods that the MTT donor avoided)
• • 3. For Part B, patients with current diagnosis of an IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk, provided that MTT does not contain traces of tree nuts, egg and milk estimated to be above the LOAEL in 4 capsules, and excluding oral allergy syndrome, excluding the food that the patient is undergoing immunotherapy to, and excluding other foods that the MTT donor avoided).
• • 4. 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.
• • 5. Recurrent or chronic infections necessitating frequent systemic (including oral) antibiotic administration.
• • 6. Patients on chronic systemic immunosuppressive therapies.
• • 7. Patients who are diagnosed with active, chronic urticaria.
• • 8. Patients who have received peanut oral immunotherapy within the past 6 months (Part A only).
• • 9. Patients who are on the up-dosing phase of aeroallergen immunotherapy or patients who have received Omalizumab or dupilumab therapy within the past 6 months.
• • 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 third 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 rheumatologic conditions. Exceptions can be made per PI discretion if illness is not expected to affect allergies or treatment.
• • 14. Patients with neutropenia \<1000 cells/uL
• • 15. Patients participating or planning to participate in the next 6 months in interventional research trials. Exceptions can be made per PI discretion.
• • 16. Patients who have received systemic corticosteroids therapy for 1 week or more over the past 60 days.
• • 17. Patient with an allergy to Vancomycin or Neomycin or any component to the capsules.