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Tests treatment safety and results for Allergy, Peanut
Official title Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients
ClinicalTrials.gov ID: NCT05695261
What this study is testing
What is Microbial Transplantation Therapy?
Microbial Transplantation Therapy is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for allergy, peanut.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- The study will enroll 24 peanut allergic patients aged 12-17 who meet the eligibility criteria in Part A and 13 people aged 12-17 years who meet...
- Develop dose limiting symptoms to peanut during a DPBCFC conducted in accordance with PRACTALL (Practical Issues in Allergology, Joint United...
- Has a positive SPT to peanut (≥3mm) and/or a positive peanut-specific IgE \>0.35kU/L (Part A only).
- For asthmatic patients, has a Spirometry or Peak Flow with Measurement of FEV1\>=80% of predicted
- Has a negative urine hCG test if a female participant.
You likely can't join if
- people who fall into any of the following exclusion criteria at the time of screening are not eligible for enrollment into the study.
- Patients with a history of severe anaphylaxis to any food (hypotension requiring vasopressor support, hypoxia requiring mechanical ventilation, or...
- For Part A, patients with current diagnosis of an IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk...
- For Part B, patients with current diagnosis of an IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk...
- Patients with chronic illness other than controlled asthma that is mild intermittent, mild- persistent or moderate persistent, mild eczema and...
- Recurrent or chronic infections necessitating frequent systemic (including oral) antibiotic administration.
See the full eligibility criteria
- The study will enroll 24 peanut allergic patients aged 12-17 who meet the eligibility criteria in Part A and 13 people aged 12-17 years who meet eligibility criteria in Part B. Male and female young adults aged 12-17...
- 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 1 mg, 3 mg, 10 mg, 30 mg, or...
- Has a positive SPT to peanut (≥3mm) and/or a positive peanut-specific IgE \>0.35kU/L (Part A only).
- For asthmatic patients, has a Spirometry or Peak Flow with Measurement of FEV1\>=80% of predicted
- Has a negative urine hCG test if a female participant.
- Agrees to use an acceptable single-barrier form of birth control from enrollment through the exit DBPCFC study visit if female of childbearing potential and sexually active. An example of a single-barrier method of...
- Able to swallow 2 empty capsules size 00.
- Able to give informed assent and guardian willing to give informed consent.
- Willing and able to participate in the study requirements, including study visits, food challenges, serial stool collection
- Willing to undergo telephone or email follow-up to assess for safety and adverse events.
- Subject has been on maintenance peanut oral immunotherapy for at least a year (part B only).
- people who fall into any of the following exclusion criteria at the time of screening are not eligible for enrollment into the study.
- Patients with a history of severe anaphylaxis to any food (hypotension requiring vasopressor support, hypoxia requiring mechanical ventilation, or neurological compromise)
- For Part A, patients with current diagnosis of an IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk, provided that MTT does not contain traces of these food estimated to be...
- For Part B, patients with current diagnosis of an IgE mediated reactions to food (excluding allergic reactions to peanut, tree nuts, egg and milk, provided that MTT does not contain traces of tree nuts, egg and milk...
- 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...
- Recurrent or chronic infections necessitating frequent systemic (including oral) antibiotic administration.
- Patients on chronic systemic immunosuppressive therapies.
- Patients who are diagnosed with active, chronic urticaria.
- Patients who have received peanut oral immunotherapy within the past 6 months (Part A only).
- Patients who are on the up-dosing phase of aeroallergen immunotherapy or patients who have received Omalizumab or dupilumab therapy within the past 6 months.
- 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 third 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...
- Patient with current rheumatologic conditions. Exceptions can be made per PI discretion if illness is not expected to affect allergies or treatment.
- Patients with neutropenia \<1000 cells/uL
- Patients participating or planning to participate in the next 6 months in treatment research trials. Exceptions can be made per PI discretion.
- Patients who have received systemic corticosteroids therapy for 1 week or more over the past 60 days.
- Patient with an allergy to Vancomycin or Neomycin or any component to the capsules.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.