NCT07107451

Evaluation of the Acquisition of Sustained Unresponsiveness (SU) to Sesame Protein Following Low-dose Oral Immunotherapy - Long-term Follow-up of Patients From the RCT Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients, NCT06261554.

Not yet recruiting NA Last updated 1 August 2025

What this trial tests

NA trial testing OIT with low dose sesame protein in Food Allergy in Children in 39 participants. Not yet recruiting.

Timeline

1 August 2025

Primary endpoint
1 December 2028

1 May 2029

Quick facts

Lead sponsor	Medical University of Warsaw
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	1 August 2025
Primary completion	1 December 2028
Estimated completion	1 May 2029
Sites	1 location across Poland

Drugs / interventions tested

• OIT with low dose sesame protein

Conditions studied

• Food Allergy in Children — all drugs for Food Allergy in Children →

Sponsor

Medical University of Warsaw

Who can join

Adults 3 to 17, any sex, with Food Allergy in Children. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Sustained unresponsiveness determined by the outcome of the OFC
  Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
  Percentage of patients achieving sustained unresponsiveness after low-dose (300 mg) sesame oral immunotherapy, defined as tolerating 4 g of sesame in OFC after 4 weeks of sesame avoidance.

Sponsor's own description

This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy and Safety of Low-Dose Sesame Oral Immunotherapy in Pediatric Patients", NCT06261554. At the end of the original RCT all participants will undergo an open Oral Food Challenge (OFC) to assess desensitization after 3 months on the maintenance dose of OIT. Patients who have completed the first part of the study will be invited to the current part of the project:

* First arm (initial experimental group) - patients will continue oral immunotherapy (OIT) with low dose of sesame protein (300mg) for the next 8 months (+/- 3 weeks).
* Second arm (initial control group - one year on a sesame elimination diet) - patients will begin OIT following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months (+/- 3 weeks).

After an additional 8 months (+/- 3 weeks) of OIT, all study participants will undergo a 4-week cessation of treatment, followed by an open Oral Food Challenge (OFC) to assess the development of sustained unresponsiveness (SU).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.