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

IPSC AG

Status: Completed

Conditions: Histamine Intolerance

Treatments: Dietary Supplement: DAOSiN®/ Placebo & ProvokAmin® Ingestion; Procedure: Drawing blood, measuring BP & pulse

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02418221

Provokamin01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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72 participants in 1 patient group

DAOSiN®/ Placebo & ProvokAmin® Ingestion

Experimental group

Description:

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.

Treatment:

Dietary Supplement: DAOSiN®/ Placebo & ProvokAmin® Ingestion

Procedure: Drawing blood, measuring BP & pulse