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Completed

NCT Number: NCT02418221

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

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.

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Key information

Conditions

Histamine Intolerance

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Environmental Dermatology and Venereology, Medical University of Graz

Graz, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DAOSiN®/ Placebo & ProvokAmin® Ingestion

Dietary Supplement

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

Drawing blood, measuring BP & pulse

Procedure

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

Primary outcomes

  1. Reduction of biogenic amine symptoms (determined via symptom score)

    Time frame: 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 outcomes

  1. Serological parameters

    Time frame: 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

Sponsors and collaborators

Lead sponsor

IPSC AG

Industry

Collaborators

  • Medical University of Graz
  • Sciotec Diagnostic Technologies GmbH

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Apr 16, 2015
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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