A Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase Supplementation
A Doubleblind, Placebo-controlled, Cross-over Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase (DAOSiN®) Supplementation in Case of DAO Enzyme Deficiency
1 other identifier
interventional
72
1 country
1
Brief Summary
This study aims to define a provocation test for histamine intolerance (aka. biogenic amine intolerance syndrome) and test the capability of an oral enzyme supplementation to ameliorate this condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 16, 2015
CompletedApril 16, 2015
April 1, 2015
9 months
September 1, 2014
April 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of biogenic amine symptoms (determined via symptom score)
The primary parameter is the reduction of clinical symptoms caused by the ingestion of biogenic amines by the preventive oral administration of DAOSiN®. A symptom score quantifying the subjective single symptoms is used as measuring parameter.
24 hrs after start of provocation
Secondary Outcomes (1)
Serological parameters
Up to 90 min after provocation
Study Arms (1)
DAOSiN®/ Placebo & ProvokAmin® Ingestion
EXPERIMENTALA sample of blood is drawn from Patient, blood pressure \& pulse are recorded. Patient will ingest 2 capsules of either DAOSiN® or Placebo, followed by 2 tablets of ProvokAmin 20 minutes later. After an additional 40 minutes blood pressure and pulse are recorded and another sample of blood is drawn. Patient is handed a questionaire for self-evaluation to record any symptoms for the following After between 7 and 15 days the whole cycle is repeated switching between active treatment and Placebo.
Interventions
Proband is randomly assigned Daosin® or the Placebo before provocation with ProvokAmin®
Taking of a blood sample and recording of blood pressure \& pulse
Eligibility Criteria
You may qualify if:
- Persons suspected of suffering from BAIS (BAIS Score ≥ 50) according the the questionaire used for histamine intolerance so far
You may not qualify if:
- pregnancy
- coronary heart disease
- labile hypertension
- bronchial asthma
- periodical therapy using H1-blockers
- chirurgical intervention with the GI tract within the previous 3 months
- participation in a clinical trial within the previous 4 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IPSC AGlead
- Medical University of Grazcollaborator
- Sciotec Diagnostic Technologies GmbHcollaborator
Study Sites (1)
Department of Environmental Dermatology and Venereology, Medical University of Graz
Graz, 8036, Austria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Albert Missbichler, PhD
Sciotec Diagnostic Technologies GmbH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2014
First Posted
April 16, 2015
Study Start
February 1, 2014
Primary Completion
November 1, 2014
Study Completion
April 1, 2015
Last Updated
April 16, 2015
Record last verified: 2015-04