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

Primary Purpose

Allergy, Peanut, Peanut Allergy, Peanut Hypersensitivity

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Microbial Transplantation Therapy
Antibiotic
Placebo (in place of MTT)
Placebo (in place of antibiotics)
Sponsored by
Rima Rachid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergy, Peanut

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 1 mg, 3 mg, 10 mg, 30 mg, or 100 mg peanut protein. Has a positive SPT to peanut (≥3mm) and/or a positive peanut-specific IgE >0.35kU/L. For asthmatic patients, has a Spirometry or Peak Flow with Measurement of FEV1>=80% of predicted Has a negative urine hCG test if a female participant. 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. Able to swallow 2 empty capsules size 00. Able to give informed assent and guardian willing to give informed consent. Willing and able to participate in the study requirements, including study visits, DBPCFCs, serial stool collection Willing to undergo telephone or email follow-up to assess for safety and adverse events. Exclusion Criteria: Patients with a history of severe anaphylaxis to any food (hypotension requiring vasopressor support, hypoxia requiring mechanical ventilation, or neurological compromise) Patients with a history of IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk, provided that MTT does not contain traces of these l food estimated to be above the LOAEL in 5 capsules combined, and excluding oral allergy syndrome). 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. Recurrent or chronic infections necessitating frequent systemic (including oral) antibiotic administration. Patients on chronic systemic immunosuppressive therapies. Patients who are diagnosed with active, chronic urticaria. Patients who have received peanut oral immunotherapy within the past 6 months. 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. Women who are pregnant or breast feeding or planning to get pregnant during the time of the study. Sexually active female patients who refuse to use contraception from enrollment through the third DBPCFC study visit 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. Patient with current rheumatologic conditions. Exceptions can be made per PI discretion if illness is not expected to affect allergies or treatment. Patients with neutropenia <1000 unit of measure? Patients participating or planning to participate in the next 6 months in interventional research trials. Exceptions can be made per PI discretion. Patients who have received systemic corticosteroids therapy for 1 week or more over the past 2 months. Patient with an allergy to Vancomycin or Neomycin

Sites / Locations

  • Boston Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

antibiotic / MTT

placebo / placebo

Arm Description

Study subjects randomized to the experimental arm will receive oral antibiotics for 7 days as a way to modulate the composition of the gastrointestinal microbiota. Upon completion of oral antibiotics, subjects randomized to the experimental arm will be administeredf MTT under medical supervision. Subjects will be monitored and then discharged. Subjects will be instructed to take MTT capsules daily for 27 days.

Study subjects randomized to the placebo arm will receive oral placebo capsules instead of oral antibiotics, for 7 days, at the same frequency and capsule amount per dose. Upon completion of 7 days of placebo (matching the antibiotics given in the experimental arm), subjects randomized to the placebo arm will be administered capsules of placebo (matching the MTT capsules given in the experimental arm) under medical supervision. Subjects will be monitored and then discharged. Subjects will be instructed to take placebo capsules daily for 27 days.

Outcomes

Primary Outcome Measures

Changes in threshold of peanut reactivity during DBPCFC (<=100 mg to 300 mg peanut protein)
Changes in threshold of peanut reactivity during DBPCFC after 28 days of MTT from <=100 mg to 300 mg peanut protein and 4 months post therapy initiation.

Secondary Outcome Measures

Changes in threshold of peanut reactivity during DBPCFC (<=100 mg to 600 mg peanut protein)
Changes in threshold of peanut reactivity during DBPCFC after 28 days of MTT from <=100 mg to 600 mg peanut protein and 4 months post therapy initiation.
Adverse Events
MTT Treatment emergent adverse events
Changes in Skin Test Wheal Size and IgE level
Changes in skin test peanut specific wheal size, peanut-specific IgE level over time
Changes in Gut Microbial Composition
Changes in gut microbial composition and persistence of that change over time
Changes in Biomarkers
Changes in biomarkers including RoRgt+Treg cells and Th2 helper cells frequencies after MTT therapy

Full Information

First Posted
January 13, 2023
Last Updated
October 10, 2023
Sponsor
Rima Rachid
Collaborators
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05695261
Brief Title
Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients
Official Title
A Phase II Trial to Evaluate the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
January 11, 2027 (Anticipated)
Study Completion Date
March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rima Rachid
Collaborators
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase II randomized double-blind placebo-controlled 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 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.
Detailed Description
This is a phase II randomized double-blind placebo-controlled trial that aims at evaluating the safety and tolerability of oral encapsulated fecal microbial transplantation therapy (MTT) in 24 peanut allergic patients, 12-17 years of age. After reacting to <=100 mg peanut protein during initial DBPCFC, patients will be randomized to receive either oral Vancomycin and Neomycin or placebo/placebo for 7 days. Patients will then come to the Experimental and Therapeutic Unit (ETU) to receive orally 5 capsules of MTT or placebo under medical supervision. Patients will then take 2 capsules of MTT or placebo daily for 27 days. Patients will return to the ETU to undergo a second DBPCFC within 2 weeks of end of MTT/placebo treatment and 4 months post MTT initiation. They will return to the ETU for an exit visit 6 months after end of treatment. Gut microbiota will be analyzed serially using state-of-the-art 16SRNA sequencing prior to transplantation, then at 4 weeks, 4-month, and 6 months post transplantation. Immunological biomarkers and mechanistic studies will be performed on blood taken at baseline, second DBPCFC visit and exit visit. Adverse events will be monitored carefully throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy, Peanut, Peanut Allergy, Peanut Hypersensitivity, Peanut-Induced Anaphylaxis, Food Allergy, Food Allergy Peanut

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized on a 1:1 ratio to receive either MTT with antibiotics or placebo/placebo. The unblinding will occur at the end of the study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
antibiotic / MTT
Arm Type
Experimental
Arm Description
Study subjects randomized to the experimental arm will receive oral antibiotics for 7 days as a way to modulate the composition of the gastrointestinal microbiota. Upon completion of oral antibiotics, subjects randomized to the experimental arm will be administeredf MTT under medical supervision. Subjects will be monitored and then discharged. Subjects will be instructed to take MTT capsules daily for 27 days.
Arm Title
placebo / placebo
Arm Type
Active Comparator
Arm Description
Study subjects randomized to the placebo arm will receive oral placebo capsules instead of oral antibiotics, for 7 days, at the same frequency and capsule amount per dose. Upon completion of 7 days of placebo (matching the antibiotics given in the experimental arm), subjects randomized to the placebo arm will be administered capsules of placebo (matching the MTT capsules given in the experimental arm) under medical supervision. Subjects will be monitored and then discharged. Subjects will be instructed to take placebo capsules daily for 27 days.
Intervention Type
Biological
Intervention Name(s)
Microbial Transplantation Therapy
Intervention Description
Subjects randomized to the MTT/antibiotic arm will be administered oral MTT capsules over the course of 28 days.
Intervention Type
Drug
Intervention Name(s)
Antibiotic
Intervention Description
Subjects randomized to the MTT/antibiotic arm will receive oral antibiotics for 7 days prior to the MTT administration visit.
Intervention Type
Other
Intervention Name(s)
Placebo (in place of MTT)
Intervention Description
Subjects randomized to the placebo arm will be administered oral placebo capsules in place of MTT over the course of 28 days.
Intervention Type
Other
Intervention Name(s)
Placebo (in place of antibiotics)
Intervention Description
Subjects randomized to the placebo arm will receive oral placebo in place of antibiotics for 7 days prior to the MTT administration visit.
Primary Outcome Measure Information:
Title
Changes in threshold of peanut reactivity during DBPCFC (<=100 mg to 300 mg peanut protein)
Description
Changes in threshold of peanut reactivity during DBPCFC after 28 days of MTT from <=100 mg to 300 mg peanut protein and 4 months post therapy initiation.
Time Frame
4 months post MTT
Secondary Outcome Measure Information:
Title
Changes in threshold of peanut reactivity during DBPCFC (<=100 mg to 600 mg peanut protein)
Description
Changes in threshold of peanut reactivity during DBPCFC after 28 days of MTT from <=100 mg to 600 mg peanut protein and 4 months post therapy initiation.
Time Frame
4 months post MTT
Title
Adverse Events
Description
MTT Treatment emergent adverse events
Time Frame
8 months
Title
Changes in Skin Test Wheal Size and IgE level
Description
Changes in skin test peanut specific wheal size, peanut-specific IgE level over time
Time Frame
8 months
Title
Changes in Gut Microbial Composition
Description
Changes in gut microbial composition and persistence of that change over time
Time Frame
8 months
Title
Changes in Biomarkers
Description
Changes in biomarkers including RoRgt+Treg cells and Th2 helper cells frequencies after MTT therapy
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 1 mg, 3 mg, 10 mg, 30 mg, or 100 mg peanut protein. Has a positive SPT to peanut (≥3mm) and/or a positive peanut-specific IgE >0.35kU/L. For asthmatic patients, has a Spirometry or Peak Flow with Measurement of FEV1>=80% of predicted Has a negative urine hCG test if a female participant. 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. Able to swallow 2 empty capsules size 00. Able to give informed assent and guardian willing to give informed consent. Willing and able to participate in the study requirements, including study visits, DBPCFCs, serial stool collection Willing to undergo telephone or email follow-up to assess for safety and adverse events. Exclusion Criteria: Patients with a history of severe anaphylaxis to any food (hypotension requiring vasopressor support, hypoxia requiring mechanical ventilation, or neurological compromise) Patients with a history of IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk, provided that MTT does not contain traces of these l food estimated to be above the LOAEL in 5 capsules combined, and excluding oral allergy syndrome). 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. Recurrent or chronic infections necessitating frequent systemic (including oral) antibiotic administration. Patients on chronic systemic immunosuppressive therapies. Patients who are diagnosed with active, chronic urticaria. Patients who have received peanut oral immunotherapy within the past 6 months. 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. Women who are pregnant or breast feeding or planning to get pregnant during the time of the study. Sexually active female patients who refuse to use contraception from enrollment through the third DBPCFC study visit 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. Patient with current rheumatologic conditions. Exceptions can be made per PI discretion if illness is not expected to affect allergies or treatment. Patients with neutropenia <1000 unit of measure? Patients participating or planning to participate in the next 6 months in interventional research trials. Exceptions can be made per PI discretion. Patients who have received systemic corticosteroids therapy for 1 week or more over the past 2 months. Patient with an allergy to Vancomycin or Neomycin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Zhang
Phone
617-919-1566
Email
Angela.Zhang@childrens.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ghinwa Al Hassanieh
Phone
617-919-6041
Email
Ghinwa.AlHassanieh@childrens.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rima Rachid
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Zhang
Phone
617-919-1566
Email
Angela.Zhang@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Farida Abi Farraj
Phone
617-919-6041
Email
Farida.AbiFarraj@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Rima Rachid, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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