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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-04-30

Brief Summary

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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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Detailed Description

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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

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Histamine Intolerance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DAOSiN®/ Placebo & ProvokAmin® Ingestion

A 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.

Group Type EXPERIMENTAL

DAOSiN®/ Placebo & ProvokAmin® Ingestion

Intervention Type DIETARY_SUPPLEMENT

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

Drawing blood, measuring BP & pulse

Intervention Type PROCEDURE

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

Interventions

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DAOSiN®/ Placebo & ProvokAmin® Ingestion

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

Intervention Type DIETARY_SUPPLEMENT

Drawing blood, measuring BP & pulse

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes