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

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ClinicalTrials.gov Identifier: NCT02960074
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Rima Rachid, Boston Children’s Hospital

Brief Summary:
This is a Phase I trial to evaluate the safety and efficacy of 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.

Condition or disease Intervention/treatment Phase
Peanut Allergy Biological: Fecal Microbiota Capsule Phase 1

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 FMT in patients with peanut allergy aged 18-40 years. A total of 10 patients with peanut allergy will be enrolled after they fail a screening food challenge to peanut. Participating will be given oral encapsulated frozen FMT over 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open Label Trial to Evaluate the Safety and Efficacy of Fecal Microbiota Transplantation in Peanut Allergic Patients
Actual Study Start Date : March 3, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fecal Microbiota Capsule
The investigational agent consists of screened-donor inoculum of a biologically active human substance (FMT). We will give oral frozen FMT over 2 days.
Biological: Fecal Microbiota Capsule
We will treat patients with oral encapsulated frozen FMT over 2 days.
Other Names:
  • FMT Therapy
  • Fecal Microbiota Transplant




Primary Outcome Measures :
  1. Presence of FMT-related adverse events grade 2 or above [ Time Frame: 12 months ]
    Presence of FMT-related adverse events grade 2 or above


Secondary Outcome Measures :
  1. 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 [ Time Frame: 1 day ]
    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

  2. Changes in threshold of peanut reactivity from 100 mg to 600 mg peanut protein during double blind placebo controlled food challenge using PRACTALL guidelines [ Time Frame: 1 day ]
    Changes in threshold of peanut reactivity from <=100 mg to 600 mg peanut protein during double blind placebo controlled food challenge using PRACTALL guidelines

  3. Changes in skin test peanut specific wheal size in mm [ Time Frame: 12 months ]
    Changes in skin test peanut specific wheal size in mm

  4. Changes in serum peanut-specific IgE level in kU/L [ Time Frame: 12 months ]
    Changes in serum peanut-specific IgE level in kU/L

  5. Changes in gut microbial composition measured in serial stool samples, using 16S RNA sequencing and persistence of that change over time [ Time Frame: 12 months ]
    Changes in gut microbial composition measured in serial stool samples, using 16S RNA sequencing and persistence of that change over time



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Allergic reaction during food challenge at 3 mg - 100 mg peanut protein.
  2. Positive SPT 5 mm wheal to peanut and/or a positive peanut-specific IgE > 0.35kU/L.
  3. Spirometry/Peak Flow with Measurement of FEV1>=80% of predicted.
  4. Negative for Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus.
  5. Negative urine pregnancy test if a female participant.
  6. Will use an acceptable double-barrier form of birth control during study.
  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.
  10. Willing to undergo telephone follow-up.

Exclusion Criteria:

  1. History of severe anaphylaxis.
  2. Required more than one dose of epinephrine to treat allergic reaction.
  3. Other food allergies excluding peanut and tree nuts.
  4. Patients with gelatin allergy
  5. Chronic illness other than controlled asthma, mild eczema, allergic rhinitis.
  6. Infections necessitating frequent systemic antibiotics.
  7. History of chronic immunosuppressive therapies.
  8. History of other chronic diseases, except for atopic conditions.
  9. More than one episode of allergic or non-allergic urticaria within a 2 month span of time, or history consistent with poorly controlled persistent asthma.
  10. Previous participation in a peanut immunotherapy protocol or on aeroallergen immunotherapy maintenance therapy for less than 6 months or who received Omalizumab therapy over the past year.
  11. Women who are pregnant or breast feeding, or planning to get pregnant during the time of the study.
  12. Sexually active female patients who refuse to use contraception for study.
  13. GI conditions including inflammatory bowel disease eosinophilic esophagitis, food protein induced enterocolitis, reflux, constipation, esophageal dysmotility, swallowing dysfunction, delayed gastric emptying syndromes, pill esophagitis or history of aspiration pneumonia within 3 months prior to screening.
  14. History of rheumatologic conditions.
  15. Direct relative with inflammatory bowel disease.
  16. Patients with any form of immunodeficiency.
  17. Patients participating or planning to participate in the next year, or have participated within the prior year in other interventional trials in which investigational drug therapy was administered.
  18. Positive for Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus.
  19. Systemic antibiotic therapy over the past 6 months or systemic corticosteroids therapy over the past 3 months.
  20. Allergic reaction during food challenge at 1 mg peanut protein.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960074


Contacts
Contact: Meghan Fitzgerald 617-355-4729 meghan.fitzgerald@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Meghan Fitzgerald    617-355-4729    meghan.fitzgerald@childrens.harvard.edu   
Principal Investigator: Rima Rachid, MD         
Sponsors and Collaborators
Rima Rachid
Investigators
Principal Investigator: Rima Rachid, MD Boston Children’s Hospital

Responsible Party: Rima Rachid, Attending Physician, Division of Immunology, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02960074     History of Changes
Other Study ID Numbers: P00020640
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rima Rachid, Boston Children’s Hospital:
Allergy, Peanut
Hypersensitivity Peanut
Peanut Allergy
Donor Feces Infusion
Fecal Transplant
Fecal Transplantation
Intestinal Microbiota Transfer
Fecal Microbiota Transplantation
Food allergy

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate