Study to Investigate the Effect of an Oral Diamine Oxidase Substitution (DAOsin) in Histamine Intolerant Patients on the Low Endogenous Diamine Oxidase Serum Activity

April 16, 2018 updated by: Sciotec Diagnostic Technologies GmbH

Pilotstudie Zur Untersuchung Der Wirkung Einer Oralen Supplementation Von Diaminooxidase (DAOsin®) Bei Histamin-Intoleranz in Bezug Auf Die Steigerung Der Erniedrigten Endogenen Diaminooxidase-Aktivität

DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake. In this uncontrolled, interventional pilot study the effect of an oral diamine oxidase substitution (DAOsin) on the reduced endogenous diamine oxidase activity in histamine intolerant patients will be examined.

Patients with a low endogenous diamine oxidase activity (below 10 Units/ml) take DAOsin for one month 3 times a day. During this month the diamine oxidase activity is tested biweekly. Afterwards a follow up period of one month without taking DAOsin follows. Again the diamine oxidase activity is tested biweekly.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Bruck an der Mur, Austria, 8600
        • Ordination für Innere Medizin und Stoffwechselzentrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diamine oxidase activity < 10 U/ml
  • >= 2 symptoms of histamine intolerance after consumption of histamine containing food
  • 18 to 80 years
  • no lactose intolerance
  • no fructose intolerance
  • no tissue transglutaminase antibodies in serum

Exclusion Criteria:

  • pregnancy and nursing
  • cardiopathy
  • instable hypertonie
  • asthma bronchial
  • lactose intolerance, fructose intolerance, coeliac disease
  • severe liver and kidney diseases
  • Known food and other allergies
  • participation in clinical study the last 4 weeks
  • recent (3 months) operation affecting the gastrointestinal tract
  • maligne, infectious or autoimmune gastrointestinal diseases (e.g. IBD)
  • taking histamine liberating drugs on a regular basis
  • taking diamine oxidase inhibiting drugs on a regular basis
  • taking diamine oxidase supplements on a regular basis in the last 4 weeks
  • H1 blocker or Montelukast Therapy 4 month before study start
  • Taking anti histaminica
  • Taking zinc preparations
  • drug, alcohol, pharmaceutical abuses
  • heavy smoking (>15 cigarettes a day)
  • Known HIV infection
  • known acute or chronic hepatitis B and C infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DAOsin treatment
Patients suffering from histamine intolerance and a diamin oxidase activity below 10 Units/ml get a DAOsin treatment for one month 3 times a day.
Dietary supplement: DAOsin
DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline activity of diamine oxidase activity in serum
Time Frame: 1 month treatment with 1 month follow up
The activity of diamine oxidase is reduced in patients suffering from histamine intolerance. Supplementation with diamine oxidase helps to reduce the level of histamine coming from food entering the circulation. It is already described that people suffering from histamine intolerance following a histamine reduced diet increase their diamine oxidase activity. The purpose is to test if an additional reduction of probably hidden sources of histamine in food through the administration of DAOsin helps to increase the endogenous diamine oxidase activity even further.
1 month treatment with 1 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms of histamine intolerance
Time Frame: 1 month with 1 month follow up
Every proband documents the severity of histamine intolerance symptoms in a questionnaire.
1 month with 1 month follow up
Histamine level in plasma
Time Frame: 1 month with 1 month follow up
Is the histamine level in plasma changing upon DAOsin treatment
1 month with 1 month follow up
Global assessment
Time Frame: 1 month with 1 month follow up
Overall condition during study
1 month with 1 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sciotec Diagnostic Technologies GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2017

Primary Completion (Actual)

December 6, 2017

Study Completion (Actual)

April 16, 2018

Study Registration Dates

First Submitted

September 26, 2017

First Submitted That Met QC Criteria

September 29, 2017

First Posted (Actual)

October 2, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTS1077/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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