---
title: A Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase Supplementation
nct_id: NCT02418221
overall_status: COMPLETED
phase: NA
sponsor: IPSC AG
study_type: INTERVENTIONAL
primary_condition: Histamine Intolerance
countries: Austria
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02418221.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02418221"
ct_last_update_post_date: 2015-04-16
last_seen_at: "2026-05-12T06:39:56.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase Supplementation

**Official 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

**NCT ID:** [NCT02418221](https://clinicaltrials.gov/study/NCT02418221)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 72
- **Lead Sponsor:** IPSC AG
- **Collaborators:** Medical University of Graz, Sciotec Diagnostic Technologies GmbH
- **Conditions:** Histamine Intolerance
- **Start Date:** 2014-02
- **Completion Date:** 2015-04
- **CT.gov Last Update:** 2015-04-16

## 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.

## Eligibility

- **Minimum age:** 19 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **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
```

## Arms

- **DAOSiN®/ Placebo & ProvokAmin® Ingestion** (EXPERIMENTAL) — 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.

## Interventions

- **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

- **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

- **Serological parameters** _(time frame: Up to 90 min after provocation)_

## Locations (1)

- Department of Environmental Dermatology and Venereology, Medical University of Graz, Graz, Austria

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of environmental dermatology and venereology, medical university of graz|graz||austria` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02418221*  
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