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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02418221

Enrollment

Registered

2015-04-16

Start date

2014-02-28

Completion date

2015-04-30

Last updated

2015-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Histamine Intolerance

Keywords

histamine, biogenic amines, diamine oxidase

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.

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.

Interventions

DIETARY_SUPPLEMENTDAOSiN®/ Placebo & ProvokAmin® Ingestion

Proband is randomly assigned Daosin® or the Placebo before provocation with ProvokAmin®

PROCEDUREDrawing blood, measuring BP & pulse

Taking of a blood sample and recording of blood pressure & pulse

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Reduction of biogenic amine symptoms (determined via symptom score)	24 hrs after start of provocation	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.

Secondary

Measure	Time frame	Description
Serological parameters	Up to 90 min after provocation	These parameters are ascertained: DAO activity and concentration of histamine in serum; blood pressure & pulse measurement before and 30/60/90 min post provocation

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026