Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 22 for:    capsule | Recruiting Studies | fecal microbiota transplantation

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02960074
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : June 7, 2019
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 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.

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 encapsulated 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.

Layout table for study information
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 Oral Encapsulated Fecal Microbiota Transplantation in Peanut Allergic Patients
Actual Study Start Date : March 3, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Develop dose limiting symptoms to peanut during a DPBCFC conducted in accordance with PRACTALL guidelines at 3 mg, 10 mg, 30 mg, or 100 mg peanut protein.
  2. Have a positive SPT to peanut (≥5mm) and/or a positive peanut-specific IgE >0.35kU/L.
  3. Have a Spirometry or Peak Flow with Measurement of FEV1>=80% of predicted
  4. Have negative test results for Hepatitis B (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 tree nuts (hypotension requiring vasopressor support, hypoxia requiring mechanical ventilation, or neurological compromise and/or ICU admission)
  2. Patients who required more than one dose of epinephrine to treat previous allergic reaction to peanut and/or tree nuts.
  3. Patients with other food allergies (i.e. IgE mediated food restrictions) excluding peanut and tree nuts.
  4. Patients with gelatin allergy.
  5. 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.
  6. Recurrent or chronic infections necessitating frequent systemic (including oral) antibiotic administration.
  7. History of chronic immunosuppressive therapies.
  8. More than two episodes of idiopathic urticaria within a 2 month span of time prior to screening, or history consistent with poorly controlled persistent asthma.
  9. 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.
  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 4 month 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 or a history of rheumatologic conditions.
  14. Patients who have a direct relative (biologic parent or sibling) with inflammatory bowel disease.
  15. Patients with any form of immunodeficiency.
  16. Patients participating or planning to participate in the next 6 months, or have participated within the prior year in other interventional trials in which investigational drug therapy was administered.
  17. Patients with positive antibody test results for HBV, HCV, or HIV.
  18. Patients who have received systemic antibiotic therapy over the past 6 weeks or systemic corticosteroids therapy for 1 week or more over the past 3 months.
  19. Patients who develop dose limiting symptoms to peanut during a DPBCFC conducted in accordance with PRACTALL guidelines 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
Layout table for location contacts
Contact: Leigh Keating 857-218-5331 Leigh.Keating@childrens.harvard.edu
Contact: Meghan Fitzgerald 617-355-4729 meghan.fitzgerald@childrens.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Leigh Keating    857-218-5331    Leigh.Keating@childrens.harvard.edu   
Principal Investigator: Rima Rachid, MD         
Sponsors and Collaborators
Rima Rachid
Investigators
Layout table for investigator information
Principal Investigator: Rima Rachid, MD Boston Children’s Hospital

Layout table for additonal information
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: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for MeSH terms
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate