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Evaluating the Safety and Efficacy of Oral Encapsulated Fecal Microbiota Transplant in Peanut Allergic Patients

Primary Purpose

Peanut Allergy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fecal Microbiota Capsule
Sponsored by
Rima Rachid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring Allergy, Peanut, Hypersensitivity Peanut, Peanut Allergy, Donor Feces Infusion, Fecal Transplant, Fecal Transplantation, Intestinal Microbiota Transfer, Fecal Microbiota Transplantation, Food allergy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion 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 3 mg, 10 mg, 30 mg, or 100 mg peanut protein.
  2. Has a positive SPT to peanut (≥5mm) and/or a positive peanut-specific IgE >0.35kU/L.
  3. Has a Spirometry or Peak Flow with Measurement of FEV1>=80% of predicted
  4. Have negative test results for Hepatitis B surface antigen and antibodies (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 treenuts (hypotension requiring vasopressor support, hypoxia requiring mechanical ventilation, or neurological compromise and/or ICU admission)
  2. Patients with other food allergies (i.e. IgE mediated food restrictions not including oral allergy syndrome) excluding peanut and tree nuts.
  3. Patients with Bovine gelatin allergy.
  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. History of chronic immunosuppressive therapies.
  7. Patients who are diagnosed with active, chronic urticaria.
  8. 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.
  9. Women who are pregnant or breast feeding, or planning to get pregnant during the time of the study.
  10. Sexually active female patients who refuse to use contraception from enrollment through the 4 month DBPCFC study visit
  11. 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.
  12. Patient with current or a history of rheumatologic conditions. Exceptions can be made per PI discretion if illness is not expected to affect allergies or treatment.
  13. Patients who have a direct relative (biologic parent or sibling) with inflammatory bowel disease.
  14. Patients with any form of immunodeficiency.
  15. Patients participating or planning to participate in the next 6 months. Exceptions can be made per PI discretion.
  16. Patients with positive antibody test results for HBV, HCV, or HIV.
  17. Patients who have received systemic corticosteroids therapy for 1 week or more over the past 3 months.
  18. Patients who develop dose limiting symptoms to peanut during a DPBCFC conducted in accordance with PRACTALL guidelines at 1 mg peanut protein.
  19. Patient with an allergy to Vancomycin, Neomycin or metronidazole (for those who will receive antibiotic pre-treatment)

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Non-antibiotics Arm

Antibiotics Arm

Arm Description

The first 10 patients will not receive antibiotics prior to receiving the investigational agent, which consists of screened-donor inoculum of a biologically active human substance (FMT). We will give oral frozen FMT over 2 days.

An additional 5 patients will receive antibiotics prior to receiving the investigational agent, which consists of screened-donor inoculum of a biologically active human substance (FMT). We will give oral frozen FMT over 2 days.

Outcomes

Primary Outcome Measures

Presence of FMT-related adverse events grade 2 or above
Presence of FMT-related adverse events grade 2 or above

Secondary Outcome Measures

Changes in threshold of peanut reactivity during a double blind placebo controlled food challenge from 100 mg to 300 mg peanut protein, using PRACTALL guidelines
To evaluate whether FMT therapy alone or after antibiotic pretreatment can increase the threshold of peanut sensitivity during a double blind placebo controlled food challenge from 100 mg peanut protein to 300 mg.
Changes in threshold of peanut reactivity from 100 mg to 600 mg peanut protein during double blind placebo controlled food challenge using PRACTALL guidelines
To evaluate whether FMT therapy alone or after antibiotic pretreatment can increase the threshold of peanut sensitivity during a double blind placebo controlled food challenge from 100 mg peanut protein to 600 mg
Changes in skin test peanut specific wheal size in mm
To evaluate the changes following FMT (with and without antibiotics), to peanut specific skin prick test.
Changes in serum peanut-specific IgE level in kU/L
To evaluate the changes following FMT (with and without antibiotics), to serum peanut-specific IgE level in kU/L
Changes in gut microbial composition measured in serial stool samples, using 16S RNA sequencing and persistence of that change over time
To evaluate the changes following FMT (with and without antibiotics), to gut microbial composition measured in serial stool samples, using 16S RNA sequencing and persistence of that change over time

Full Information

First Posted
November 7, 2016
Last Updated
September 2, 2021
Sponsor
Rima Rachid
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1. Study Identification

Unique Protocol Identification Number
NCT02960074
Brief Title
Evaluating the Safety and Efficacy of Oral Encapsulated Fecal Microbiota Transplant in Peanut Allergic Patients
Official Title
A Phase I Open Label Trial to Evaluate the Safety and Efficacy of Oral Encapsulated Fecal Microbiota Transplantation in Peanut Allergic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
July 28, 2021 (Actual)
Study Completion Date
July 28, 2021 (Actual)

3. Sponsor/Collaborators

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

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 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.
Detailed Description
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 15 patients with peanut allergy will be enrolled after they fail a screening food challenge to peanut. 10 patients will be given oral encapsulated frozen FMT over 1-2 days. 5 additional patients will receive antibiotics prior to being given oral encapsulated frozen FMT over 1-2 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
Allergy, Peanut, Hypersensitivity Peanut, Peanut Allergy, Donor Feces Infusion, Fecal Transplant, Fecal Transplantation, Intestinal Microbiota Transfer, Fecal Microbiota Transplantation, Food allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-antibiotics Arm
Arm Type
Experimental
Arm Description
The first 10 patients will not receive antibiotics prior to receiving the investigational agent, which consists of screened-donor inoculum of a biologically active human substance (FMT). We will give oral frozen FMT over 2 days.
Arm Title
Antibiotics Arm
Arm Type
Experimental
Arm Description
An additional 5 patients will receive antibiotics prior to receiving the investigational agent, which consists of screened-donor inoculum of a biologically active human substance (FMT). We will give oral frozen FMT over 2 days.
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Capsule
Other Intervention Name(s)
FMT Therapy, Fecal Microbiota Transplant
Intervention Description
We will treat patients with oral encapsulated frozen FMT over 2 days.
Primary Outcome Measure Information:
Title
Presence of FMT-related adverse events grade 2 or above
Description
Presence of FMT-related adverse events grade 2 or above
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in threshold of peanut reactivity during a double blind placebo controlled food challenge from 100 mg to 300 mg peanut protein, using PRACTALL guidelines
Description
To evaluate whether FMT therapy alone or after antibiotic pretreatment can increase the threshold of peanut sensitivity during a double blind placebo controlled food challenge from 100 mg peanut protein to 300 mg.
Time Frame
1 day
Title
Changes in threshold of peanut reactivity from 100 mg to 600 mg peanut protein during double blind placebo controlled food challenge using PRACTALL guidelines
Description
To evaluate whether FMT therapy alone or after antibiotic pretreatment can increase the threshold of peanut sensitivity during a double blind placebo controlled food challenge from 100 mg peanut protein to 600 mg
Time Frame
1 day
Title
Changes in skin test peanut specific wheal size in mm
Description
To evaluate the changes following FMT (with and without antibiotics), to peanut specific skin prick test.
Time Frame
12 months
Title
Changes in serum peanut-specific IgE level in kU/L
Description
To evaluate the changes following FMT (with and without antibiotics), to serum peanut-specific IgE level in kU/L
Time Frame
12 months
Title
Changes in gut microbial composition measured in serial stool samples, using 16S RNA sequencing and persistence of that change over time
Description
To evaluate the changes following FMT (with and without antibiotics), to gut microbial composition measured in serial stool samples, using 16S RNA sequencing and persistence of that change over time
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 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 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. Willing and able to participate in the study requirements, including study visits, DBPCFCs, serial stool collection Willing to undergo telephone follow-up to assess for safety and adverse events. 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) 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. Recurrent or chronic infections necessitating frequent systemic (including oral) antibiotic administration. 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. 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 4 month 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 or a history of rheumatologic conditions. Exceptions can be made per PI discretion if illness is not expected to affect allergies or treatment. Patients who have a direct relative (biologic parent or sibling) with inflammatory bowel disease. Patients with any form of immunodeficiency. Patients participating or planning to participate in the next 6 months. Exceptions can be made per PI discretion. Patients with positive antibody test results for HBV, HCV, or HIV. Patients who have received systemic corticosteroids therapy for 1 week or more over the past 3 months. Patients who develop dose limiting symptoms to peanut during a DPBCFC conducted in accordance with PRACTALL guidelines at 1 mg peanut protein. Patient with an allergy to Vancomycin, Neomycin or metronidazole (for those who will receive antibiotic pre-treatment)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rima Rachid, MD
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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33463542
Citation
Berin MC. Dysbiosis in food allergy and implications for microbial therapeutics. J Clin Invest. 2021 Jan 19;131(2):e144994. doi: 10.1172/JCI144994.
Results Reference
derived

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Evaluating the Safety and Efficacy of Oral Encapsulated Fecal Microbiota Transplant in Peanut Allergic Patients

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