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Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures. (FROST)

3. november 2026 opdateret af: Philippe Bégin

A Randomized Controlled 2×2 Factorial Study Evaluating Sucrose and Cold for the Treatment of Oral Pruritus During Allergy Procedures

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):

  • 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)
  • Control (20 mL room-temperature water)

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

8 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Aged 8 years and older.
  • Have a clinically diagnosed IgE-mediated food allergy, supported by a compatible clinical history and evidence of IgE sensitization (e.g., skin prick testing and/or serum food-specific IgE), as determined by the treating allergist.
  • Undergoing an oral food challenge or initiating oral immunotherapy / undergoing an oral immunotherapy dose escalation.
  • Develop oral pruritus following allergen administration with a minimum score of 3/10 on the ICH Numeric Rating Scale (ICH NRS).
  • Be able to assess and report their symptoms using the ICH NRS.
  • Provide informed consent to participate in the study (and assent, where applicable, in accordance with local regulations).

Exclusion Criteria:

  • Any oral condition or pathology that could interfere with the perception, assessment, or interpretation of oral pruritus symptoms.
  • Presence or development of systemic allergic symptoms for which epinephrine administration would be clinically indicated.
  • Poorly controlled diabetes mellitus, as defined by the treating physician.
  • Any condition affecting oral sensation or the ability to accurately communicate symptoms using the ICH NRS.
  • Cold urticaria or significant hypersensitivity to cold.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Sucrose only

3.5 g granulated sugar
Andet: Food (sucrose)

Sucrose only (3.5 g granulated sugar)
Aktiv komparator: Cold only

20 mL of ice in the form of popsicle
Andet: Food (popsicle)

Cold only (20 mL of ice in the form of popsicle)
Aktiv komparator: Sucrose and cold

20 mL frozen sucrose solution
Andet: Food(Sucrose and cold)

Sucrose + cold (20 mL frozen sucrose solution)
Placebo komparator: Water

20 mL room-temperature water
Andet: Water (Placebo)

20 mL room-temperature water

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area under the curve (AUC) of ICH NRS scores
Tidsramme: From baseline (pre-intervention) through 15 minutes post-intervention.

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.
From baseline (pre-intervention) through 15 minutes post-intervention.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to reduction of at least 2 points from the baseline ICH NRS score.
Tidsramme: From baseline (pre-intervention) through 15 minutes post-intervention.

A reduction of at least 2 points on the 11-point Numerical Rating Scale (0-10) indicates an improvement in pruritus intensity.
From baseline (pre-intervention) through 15 minutes post-intervention.
Time to complete resolution of oral pruritus (ICH NRS score of 0).
Tidsramme: From baseline (pre-intervention) through 15 minutes post-intervention.

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.
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.
Tidsramme: From baseline (pre-intervention) through 15 minutes post-intervention.

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.
From baseline (pre-intervention) through 15 minutes post-intervention.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Philippe Bégin

Samarbejdspartnere

Centre hospitalier de l'Université de Montréal (CHUM)
Sainte Justine Hospital Research Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

27. oktober 2026

Først indsendt, der opfyldte QC-kriterier

3. november 2026

Først opslået (Faktiske)

4. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MP-21-2027-10364

Plan for individuelle deltagerdata (IPD)

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