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Peanut AllergyPhase 1NCT02960074

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

A Phase 1 study testing Fecal Microbiota Capsule in people with Peanut Allergy, run by Rima Rachid at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Peanut Allergy
What is being tested?
Fecal Microbiota Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
3 Mar 2017to 28 Jul 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: A Phase I Open Label Trial to Evaluate the Safety and Efficacy of Oral Encapsulated Fecal Microbiota Transplantation in Peanut Allergic Patients

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.

Read the 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.

Conditions
Peanut Allergy
Being tested
Fecal Microbiota Capsule
Keywords
Allergy, Peanut, Hypersensitivity Peanut, Peanut Allergy, Donor Feces Infusion, Fecal Transplant, Fecal Transplantation, Intestinal Microbiota Transfer, Fecal Microbiota Transplantation, Food allergy
Medical subject headings
Peanut Hypersensitivity, Food Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal Microbiota CapsuleBiological

    Also called FMT Therapy, Fecal Microbiota Transplant

    We will treat patients with oral encapsulated frozen FMT over 2 days.

Study groups in NCT02960074
Study groupRoleWhat they receive
Non-antibiotics ArmExperimentalThe 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.
Receives: Biological: Fecal Microbiota Capsule
Antibiotics ArmExperimentalAn 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.
Receives: Biological: Fecal Microbiota Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Presence of FMT-related adverse events grade 2 or above

    Measured: 12 months

Secondary outcomes (5)

  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

    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.

    Measured: 1 day

  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

    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

    Measured: 1 day

  3. 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.

    Measured: 12 months

  4. 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

    Measured: 12 months

  5. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2016 (estimated)
  2. Study start3 Mar 2017
  3. Primary completion28 Jul 2021
  4. Study completion28 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02960074
Sponsor's protocol ID
P00020640
Status last verified
Oct 2026
First submitted
7 Nov 2016
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Berin MC. Dysbiosis in food allergy and implications for microbial therapeutics. J Clin Invest. 2021 Jan 19;131(2):e144994. doi: 10.1172/JCI144994.

    PubMed 33463542

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fecal Microbiota Capsule in people with Peanut Allergy, run by Rima Rachid at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of FMT-related adverse events grade 2 or above (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02960074, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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