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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Carlos de Lecea, MD
- Telefonnummer: +34 609 02 53 61
- E-post: cdelecea@biotexia.com
Studera Kontakt Backup
- Namn: Alejandra Gadea, PhD
- E-post: agadea@biotexia.com
Studieorter
-
-
Barcelona
-
Barcelona, Barcelona, Spanien, 08041
- Rekrytering
- Centre d'Investigació del Medicament (CIM-IR Sant Pau)
-
Kontakt:
- Pol Molina, PharmD
- Telefonnummer: +34 93 553 78 55
- E-post: pmolinap@santpau.cat
-
-
Spain
-
Barcelona, Spain, Spanien, 08041
- Rekrytering
- Hospital de la Santa Creu i Sant Pau
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebo
Placebo |
Matching placebo capsule administered before a standardized oral histamine challenge in a randomized, double-blind, crossover study. |
|
Experimentell: DAO
|
Oral diamine oxidase (DAO) dietary supplement administered before a standardized oral histamine challenge in a randomized, double-blind, crossover study. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall symptom burden following oral histamine challenge
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DAOH-26
Plan för individuella deltagardata (IPD)
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