Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures. (FROST)
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ginevra Lacatusu
- 電話番号：2670 514-345-4931
- メール：ginevra.lacatusu.hsj@ssss.gouv.qc.ca
研究場所
-
-
Quebec
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Montreal、Quebec、カナダ、H2X 0C1
- CHUM
-
コンタクト：
- Philippe Bégin
- 電話番号：2668 514-345-4931
- メール：philippe.begin.med@ssss.gouv.qc.ca
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Montreal、Quebec、カナダ、H3T1C5
- Chu Sainte-Justine
-
コンタクト：
- Maitena montuzet
- 電話番号：117375 514-345-4931
- メール：maitena.montuzet.hsj@ssss.gouv.qc.ca
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Sucrose only
3.5 g granulated sugar |
Sucrose only (3.5 g granulated sugar) |
|
アクティブコンパレータ：Cold only
20 mL of ice in the form of popsicle |
Cold only (20 mL of ice in the form of popsicle) |
|
アクティブコンパレータ：Sucrose and cold
20 mL frozen sucrose solution |
Sucrose + cold (20 mL frozen sucrose solution) |
|
プラセボコンパレーター：Water
20 mL room-temperature water |
20 mL room-temperature water |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Area under the curve (AUC) of ICH NRS scores
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to reduction of at least 2 points from the baseline ICH NRS score.
時間枠：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).
時間枠：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.
時間枠：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.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MP-21-2027-10364
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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