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Completed

NCT Number: NCT03298568

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

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.

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Key information

Conditions

Food Intolerance Histamine Intolerance Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordination für Innere Medizin und Stoffwechselzentrum

Bruck an der Mur, 8600, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DAOsin

Dietary Supplement

DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sciotec Diagnostic Technologies GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 2, 2017
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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