RECRUITING

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

Conditions

Allergy, Peanut Peanut Allergy Peanut Hypersensitivity Peanut-Induced Anaphylaxis Food Allergy Food Allergy Peanut

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase II trial that aims at evaluating the safety and tolerability of oral encapsulated fecal microbial transplantation therapy (MTT) in peanut allergic patients. In this research the investigators would like to learn more about ways to treat peanut allergies. The primary objective for Part A is to evaluate whether MTT with antibiotic pretreatment can increase the threshold of peanut reactivity during a double-blind placebo-controlled food challenge from \<=100 mg peanut protein to 300 mg after 28 days of MTT /placebo therapy and 4 months post therapy initiation. The primary objective for Part B is to evaluate whether MTT with antibiotic pretreatment can lead to sustained unresponsiveness (SU) defined as tolerating the same dose of peanut protein administered during a food challenge at baseline and 12 weeks after OIT cessation.

Official Title

A Phase II Trial to Evaluate the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients

Quick Facts

Study Start:2023-06-08

Study Completion:2027-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05695261

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
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).	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.

Inclusion Criteria

Exclusion Criteria

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).

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.

Contacts and Locations

Study Contact

Melanie Benitez

CONTACT

617-355-6117

Melanie.Benitez@childrens.harvard.edu

Andrew Xuan

CONTACT

Andrew.Xuan@childrens.harvard.edu

Principal Investigator

Rima Rachid

PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Study Locations (Sites)

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Rima Rachid

Rima Rachid, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-08

Study Completion Date2027-03-01

Study Record Updates

Study Start Date2023-06-08

Study Completion Date2027-03-01

Terms related to this study

Additional Relevant MeSH Terms

Allergy, Peanut
Peanut Allergy
Peanut Hypersensitivity
Peanut-Induced Anaphylaxis
Food Allergy
Food Allergy Peanut