An interventional study of Food (sucrose) and Food (popsicle) in Allergy, Food Allergies and Oral Pruritus, sponsored by Philippe Bégin. Not yet recruiting at 2 sites in Canada. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Philippe Bégin · Not applicable, Interventional, and Treatment
This is a two-center, randomized, open-label, factorial controlled trial. This trial aims to evaluate the efficacy of exposure to sucrose and ice, alone and in combination, compared to control, in reducing oral pruritus during allergy procedures.
The population will include patients aged 8 years and older presenting with oral pruritus in the context of an oral food challenge or an oral immunotherapy dose increase at the allergy clinic.
Clinically significant oral pruritus will be defined as a pruritus intensity of ≥3/10 on the ICH NRS, and a symptom bothersome enough that the patient would normally seek treatment.
Eligible participants will be randomized to one of four groups (1:1:1:1 ratio):
Participants will be asked to report when the pruritus has decreased to a level at which they would not normally seek treatment, as well as when it has completely resolved.
The evolution of oral pruritus will be assessed using an 11-point Numeric Rating Scale (ICH NRS). Pruritus intensity will be measured every 30 seconds during the first 5 minutes after administration of the study intervention and then every 1 minute until 15 minutes post-intervention.
348 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 48 is below the median of 60 across 219 interventional studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Philippe Bégin is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Compared within Food Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
3.5 g granulated sugar
Other: Food (sucrose)
20 mL of ice in the form of popsicle
Other: Food (popsicle)
20 mL frozen sucrose solution
Other: Food(Sucrose and cold)
20 mL room-temperature water
Other: Water (Placebo)
Sucrose only (3.5 g granulated sugar)
Cold only (20 mL of ice in the form of popsicle)
Sucrose + cold (20 mL frozen sucrose solution)
20 mL room-temperature water
Area under the curve (AUC) of ICH NRS scores
Pruritus intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicate greater pruritus intensity and therefore a worse outcome.
Time frame: From baseline (pre-intervention) through 15 minutes post-intervention.
Time to reduction of at least 2 points from the baseline ICH NRS score.
A reduction of at least 2 points on the 11-point Numerical Rating Scale (0-10) indicates an improvement in pruritus intensity.
Time frame: From baseline (pre-intervention) through 15 minutes post-intervention.
Time to complete resolution of oral pruritus (ICH NRS score of 0).
Complete resolution of oral pruritus is defined as an Intra-episode Clinical Numerical Rating Scale (ICH NRS) score of 0, corresponding to no itching. The scale ranges from 0 (no itch) to 10 (worst imaginable itch), with higher scores indicating greater pruritus severity and therefore a worse outcome.
Time frame: From baseline (pre-intervention) through 15 minutes post-intervention.
Time to a decrease in oral pruritus intensity to a level at which the participant would normally not seek treatment.
Time from intervention administration to the first assessment at which oral pruritus intensity decreases to a level that the participant reports would not normally prompt them to seek treatment. Pruritus intensity is assessed using the Intra-episode Clinical Numerical Rating Scale (ICH NRS), ranging from 0 (no itch) to 10 (worst imaginable itch), with higher scores indicating greater pruritus intensity and a worse outcome.
Time frame: From baseline (pre-intervention) through 15 minutes post-intervention.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 83 non-industry interventional studies with no phase under Food Hypersensitivity, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 50. This study's planned 7 months is below that.
Counting every sponsor, half of 86 studies reached it within 29 months; a quarter within 13 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Philippe Bégin