NCT02418221

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: IPSC AG · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Histamine Intolerance

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-11-01
• Completion: 2015-04-01
• First posted: 2015-04-16
• Last updated: 2015-04-16

Locations

1 site across 1 country: Austria