Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-24 @ 12:12 PM
Study NCT ID:
NCT05695261
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2023-01-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients
Sponsor:
Rima Rachid
Organization:
Study Overview
Official Title:
A Phase II Trial to Evaluate the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: