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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03298568
Recruitment Status : Completed
First Posted : October 2, 2017
Last Update Posted : April 18, 2018
Information provided by (Responsible Party):
Sciotec Diagnostic Technologies GmbH

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.

Condition or disease Intervention/treatment Phase
Food Intolerance Histamine Intolerance Dietary Supplement: DAOsin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 21, 2017
Actual Primary Completion Date : December 6, 2017
Actual Study Completion Date : April 16, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Histamine

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Histamine level in plasma [ Time Frame: 1 month with 1 month follow up ]
    Is the histamine level in plasma changing upon DAOsin treatment

  3. Global assessment [ Time Frame: 1 month with 1 month follow up ]
    Overall condition during study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03298568

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Ordination für Innere Medizin und Stoffwechselzentrum
Bruck an der Mur, Austria, 8600
Sponsors and Collaborators
Sciotec Diagnostic Technologies GmbH
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sciotec Diagnostic Technologies GmbH Identifier: NCT03298568    
Other Study ID Numbers: BTS1077/17
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sciotec Diagnostic Technologies GmbH:
food intolerance
histamine intolerance
diamine oxidase
Additional relevant MeSH terms:
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Food Intolerance
Signs and Symptoms, Digestive