Effect of Oral Diamine Oxidase on Symptoms Induced by Histamine Oral Challenge
Double-Blind, Placebo-Controlled, Crossover Trial to Evaluate the Effect of Diamine Oxidase (DAO) on the Response to Oral Histamine Challenge
The goal of this clinical trial is to learn whether oral diamine oxidase (DAO) can lower symptoms caused by an oral histamine challenge in adults with self-reported food-related histamine symptoms who demonstrate responsiveness to histamine challenge during screening.
研究概览
地位
详细说明
Histamine intolerance is characterized by the occurrence of symptoms after ingestion of histamine-containing foods and may be associated with reduced degradation of dietary histamine by the enzyme diamine oxidase (DAO). Previous studies have suggested potential benefits of oral DAO supplementation; however, additional controlled clinical studies are needed using standardized histamine challenge procedures and predefined symptom assessments.
This study is a randomized, double-blind, placebo-controlled, crossover trial conducted in healthy adult volunteers who demonstrate a predefined response to histamine provocation are randomized into the treatment phase.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Carlos de Lecea, MD
- 电话号码：+34 609 02 53 61
- 邮箱：cdelecea@biotexia.com
研究联系人备份
- 姓名：Alejandra Gadea, PhD
- 邮箱：agadea@biotexia.com
学习地点
-
-
Barcelona
-
Barcelona、Barcelona、西班牙、08041
- 招聘中
- Centre d'Investigació del Medicament (CIM-IR Sant Pau)
-
接触：
- Pol Molina, PharmD
- 电话号码：+34 93 553 78 55
- 邮箱：pmolinap@santpau.cat
-
-
Spain
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Barcelona、Spain、西班牙、08041
- 招聘中
- Hospital de la Santa Creu i Sant Pau
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults aged 18 to 65 years.
- History of symptoms after consumption of foods potentially rich in histamine.
- Clinically stable and suitable for oral histamine challenge testing.
- Ability and willingness to provide informed consent.
- Willingness to comply with study procedures and restrictions.
- No clinically relevant medical history.
- No clinically significant findings during screening assessments.
- Positive response to histamine challenge during screening, according to predefined protocol criteria.
Exclusion Criteria:
- Food allergy, celiac disease, peptic ulcer disease, or esophagitis.
- Acute infection.
- Pregnancy or breastfeeding.
- History of anaphylaxis or severe reactions to histamine.
- Known intolerance to diamine oxidase.
- Severe chronic diseases or medical conditions that may increase risk.
- Excessive alcohol consumption.
- Positive drug or alcohol screening.
- Use of medications that may interfere with histamine or DAO activity.
- Severe reaction during screening histamine challenge.
- Any condition that, in the investigator's opinion, may compromise participant safety or study conduct.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Placebo
Placebo |
Matching placebo capsule administered before a standardized oral histamine challenge in a randomized, double-blind, crossover study. |
|
实验性的：DAO
|
Oral diamine oxidase (DAO) dietary supplement administered before a standardized oral histamine challenge in a randomized, double-blind, crossover study. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall symptom burden following oral histamine challenge
大体时间：0 to 4 hours after histamine challenge
|
Overall symptom burden is assessed using a study-specific symptom rating scale covering three domains: gastrointestinal, cutaneous/mucosal, and headache/neurovegetative symptoms. Each domain is rated from 0 (no symptoms) to 10 (maximum imaginable symptom intensity), resulting in a total score ranging from 0 to 30, with higher scores indicating greater symptom burden. The primary outcome is the area under the curve (AUC) of the total symptom score over the first 4 hours following the histamine challenge. |
0 to 4 hours after histamine challenge
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- DAOH-26
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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