A Phase 2 interventional study of Microbial Transplantation Therapy and Antibiotic in Allergy, Peanut, Peanut Allergy and Peanut Hypersensitivity, sponsored by Rima Rachid. Recruiting at 1 site in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Rima Rachid · Phase 2, Interventional, and Treatment
This is a phase II 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 for Part A 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. The primary objective for Part B is to evaluate whether MTT with antibiotic pretreatment can lead to sustained unresponsiveness (SU) defined as tolerating the same dose of peanut protein administered during a food challenge at baseline and 12 weeks after OIT cessation.
Part A is a This is a phase II randomized double-blind placebo-controlled arm trial that aims at evaluating the efficacy and safety and tolerability of microbial transplantation therapy (MTT) in peanut allergic patients. 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 5 capsules of MTT or placebo the next day then 2 capsules daily for 26 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.
Part B is an open label phase II arm that aims at evaluating the role of MTT in sustained unresponsiveness. Patients who are on maintenance peanut oral immunotherapy (OIT) for a year will be enrolled. They will undergo an open label oral food challenge (OFC) to determine their threshold tolerated dose, after which they will start a week of antibiotics (Vancomycin and Neomycin). Patients will receive their 4 oral capsules of MTT under medical supervision, take another 4 capsules the next day then will start 2 capsules per day for a total of 12 weeks of MTT therapy , all while continuing maintenance peanut OIT. At the end of this course, patients will undergo another open label OFC to evaluate for any change in their tolerated dose . Subjects will then stop OIT and MTT for 12 weeks and will come back for a third OFC to evaluate for any change in their tolerated dose. An exit visit will occur 6 months post end of treatment.
Gut microbiota will be analyzed serially using state-of-the-art 16SRNA sequencing at baseline, post antibiotics (and prior to MTT initiation), then at 4, 8, 12, 16, 20 and 24 weeks post MTT initiation. Immunological biomarkers and mechanistic studies will be performed on blood taken at baseline, second and third OFC and exit visit. Adverse events will be monitored carefully throughout the study.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's planned enrollment of 37 is below the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →Rima Rachid is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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The study will enroll 24 peanut allergic patients aged 12-17 who meet the eligibility criteria in Part A and 13 subjects aged 12-17 years who meet eligibility criteria in Part B.
Inclusion Criteria:
Male and female young adults aged 12-17 years, who meet all the following inclusion criteria, will be enrolled in the study.
Exclusion Criteria:
Subjects who fall into any of the following exclusion criteria at the time of screening are not eligible for enrollment into the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Microbial Transplantation Therapy · Drug: Antibiotic
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.
Other: Placebo (in place of MTT) · Other: Placebo (in place of antibiotics)
In Part B will enroll 13 participants who are peanut allergic and are on maintenance peanut oral immunotherapy (OIT). Participants will undergo an open label food challenge (OFC) up to 2,000 mg peanut protein. These participants will be pre-treated with open label oral Vancomycin and Neomycin over 7 days prior to receiving open label MTT. This part of the study is not randomized or double blind.
Biological: Microbial Transplantation Therapy · Drug: Antibiotic · Other: Oral Immunotherapy (OIT)
Participants randomized to the MTT/antibiotic arm of PART A will be administered oral MTT capsules over the course of 28 days. Participant enrolled on PART B will be administered oral MTT capsules over the course of 28 days.
Participants randomized to the MTT/antibiotic arm of PART A will receive oral antibiotics for 7 days prior to the MTT administration visit. Participant enrolled on PART B will receive oral antibiotics for 7 days prior to the MTT administration visit.
Participants randomized to the placebo arm of PART A will be administered oral placebo capsules in place of MTT over the course of 28 days.
Participants randomized to the placebo arm of PART A will receive oral placebo in place of antibiotics for 7 days prior to the MTT administration visit.
Participant enrolled on PART B will be on maintenance peanut oral immunotherapy (OIT) for their clinical care.
PART A: Changes in threshold of peanut reactivity during DBPCFC (<=100 mg to 300 mg peanut protein)
PART A: 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
PART B: Achievement of sustained unresponsiveness after 12 weeks of MTT
PART B: Achievement of sustained unresponsiveness after 12 weeks of MTT therapy combined with peanut OIT followed by 12 weeks therapy cessation
Time frame: 12 weeks
PART A: Changes in threshold of peanut reactivity during DBPCFC (<=100 mg to 600 mg peanut protein)
PART A: 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
PART A & B: Adverse Events
PART A \& B: MTT Treatment emergent adverse events
Time frame: 8 months
PART A & B: Changes in Skin Test Wheal Size and IgE level
PART A \& B: Changes in skin test peanut specific wheal size, peanut-specific IgE level over time
Time frame: 8 months
PART A & B: Changes in Gut Microbial Composition
PART A \& B: Changes in gut microbial composition and persistence of that change over time
Time frame: 8 months
PART A & B: Changes in Biomarkers
PART A \& B: Changes in biomarkers including RoRgt+Treg cells and Th2 helper cells frequencies after MTT therapy
Time frame: 8 months
PART B: Change in the tolerated dose during OFC after 12 weeks days of MTT
PART B: Change in the tolerated dose during OFC after 12 weeks days of MTT therapy combined with OIT compared to baseline.
Time frame: 12 weeks
Plan to share: No
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Started Jun 2023 (actual). Primary completion is estimated for Jan 2027, 43 months after the start.
Of 18 phase 2 interventional studies under Peanut Hypersensitivity, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 58. This study's planned 43 months is above that.
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