A Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase Supplementation

Histamine Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418221
• Other study ID #: Provokamin01
• Status: Completed
• Phase: N/A
• First received: September 1, 2014
• Last updated: April 15, 2015
• Start date: February 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: IPSC AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Description:

The clinical picture of the so-called histamine intolerance has been described by various authors since the 1990ies. However, the existence of this multifactorial condition is also being contested due to the lack of both a positive definition and unambiguous diagnostics. Various provocation studies using pure histamine or histamine-containing foods support the existence of the disease pattern, however many questions still remain open.

A lack of diamine oxidase (DAO) is considered the etiological cause of the condition. DAO is an enzyme known to degrade a wide array of biogenic amines. The aim of this study is to provoke a response in patients by oral administration of a defined mixture of biogenic amines. By administration of DAO before provocation an attenuation of the symptoms is to be expected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Persons suspected of suffering from BAIS (BAIS Score = 50) according the the questionaire used for histamine intolerance so far

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Histamine Intolerance

Intervention

Dietary Supplement:
• DAOSiN®/ Placebo & ProvokAmin® Ingestion
Proband is randomly assigned Daosin® or the Placebo before provocation with ProvokAmin®

Procedure:
• Drawing blood, measuring BP & pulse
Taking of a blood sample and recording of blood pressure & pulse

Locations

Country	Name	City	State
Austria	Department of Environmental Dermatology and Venereology, Medical University of Graz	Graz

Sponsors (3)

Lead Sponsor	Collaborator
IPSC AG	Medical University of Graz, Sciotec Diagnostic Technologies GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Serological parameters	These parameters are ascertained: DAO activity and concentration of histamine in serum; blood pressure & pulse measurement before and 30/60/90 min post provocation	Up to 90 min after provocation	No