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

Primary Purpose

Food Intolerance, Histamine Intolerance

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
DAOsin
Sponsored by
Sciotec Diagnostic Technologies GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Intolerance focused on measuring food intolerance, histamine intolerance, diamine oxidase, DAO, DAOsin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ordination für Innere Medizin und Stoffwechselzentrum

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DAOsin treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in baseline activity of diamine oxidase activity in serum
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.

Secondary Outcome Measures

Symptoms of histamine intolerance
Every proband documents the severity of histamine intolerance symptoms in a questionnaire.
Histamine level in plasma
Is the histamine level in plasma changing upon DAOsin treatment
Global assessment
Overall condition during study

Full Information

First Posted
September 26, 2017
Last Updated
April 16, 2018
Sponsor
Sciotec Diagnostic Technologies GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03298568
Brief Title
Study to Investigate the Effect of an Oral Diamine Oxidase Substitution (DAOsin) in Histamine Intolerant Patients on the Low Endogenous Diamine Oxidase Serum Activity
Official Title
Pilotstudie Zur Untersuchung Der Wirkung Einer Oralen Supplementation Von Diaminooxidase (DAOsin®) Bei Histamin-Intoleranz in Bezug Auf Die Steigerung Der Erniedrigten Endogenen Diaminooxidase-Aktivität
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
December 6, 2017 (Actual)
Study Completion Date
April 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sciotec Diagnostic Technologies GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Intolerance, Histamine Intolerance
Keywords
food intolerance, histamine intolerance, diamine oxidase, DAO, DAOsin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DAOsin treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
DAOsin
Intervention Description
DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake.
Primary Outcome Measure Information:
Title
Change in baseline activity of diamine oxidase activity in serum
Description
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.
Time Frame
1 month treatment with 1 month follow up
Secondary Outcome Measure Information:
Title
Symptoms of histamine intolerance
Description
Every proband documents the severity of histamine intolerance symptoms in a questionnaire.
Time Frame
1 month with 1 month follow up
Title
Histamine level in plasma
Description
Is the histamine level in plasma changing upon DAOsin treatment
Time Frame
1 month with 1 month follow up
Title
Global assessment
Description
Overall condition during study
Time Frame
1 month with 1 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ordination für Innere Medizin und Stoffwechselzentrum
City
Bruck an der Mur
ZIP/Postal Code
8600
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
31807350
Citation
Schnedl WJ, Schenk M, Lackner S, Enko D, Mangge H, Forster F. Diamine oxidase supplementation improves symptoms in patients with histamine intolerance. Food Sci Biotechnol. 2019 May 24;28(6):1779-1784. doi: 10.1007/s10068-019-00627-3. eCollection 2019 Dec.
Results Reference
derived

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

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