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NCT05695261 · ClinicalTrials.gov registry record · Phase 2
Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients
A Phase 2 study of Food Allergy and Peanut Allergy, sponsored by Rima Rachid.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT05695261 is a Phase 2 study of Food Allergy and Peanut Allergy that is actively recruiting participants, run by Rima Rachid. The registered enrollment target is 37 participants, below the 962-participant average among 17 other Food Allergy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05695261, a Phase 2 study of Food Allergy and Peanut Allergy, is actively recruiting participants, sponsored by Rima Rachid.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Antibiotic
- BIOLOGICAL Microbial Transplantation Therapy
- OTHER Placebo (in place of MTT)
- OTHER Placebo (in place of antibiotics)
- OTHER Oral Immunotherapy (OIT)
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2023-06-08 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05695261
The ClinicalTrials.gov registry entry for NCT05695261 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 962-participant average among 17 other Food Allergy trials with a reported enrollment target (96% lower). The listed sponsor is Rima Rachid, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Food Allergy appearing as the primary indexed condition, and to 5 interventions - of which Antibiotic is the first listed.
NCT05695261 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05695261 about?
NCT05695261 is a clinical study titled "Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients". 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 Par...
What is the current status of trial NCT05695261?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2023-06-08. Estimated completion is 2027-03-01.
What conditions does trial NCT05695261 study?
This clinical trial studies the following conditions: Food Allergy, Peanut Allergy, Food Allergy Peanut, Peanut Hypersensitivity, Allergy, Peanut.
What interventions are being tested in trial NCT05695261?
The interventions under investigation include: Antibiotic (DRUG), Microbial Transplantation Therapy (BIOLOGICAL), Placebo (in place of MTT) (OTHER), Placebo (in place of antibiotics) (OTHER), Oral Immunotherapy (OIT) (OTHER).
Who is sponsoring clinical trial NCT05695261?
This trial is sponsored by Rima Rachid, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05695261 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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