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

Study Overview
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Brief Summary
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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.

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

Conditions
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Food Intolerance, Histamine Intolerance

Intervention / Treatment
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* Dietary Supplement: DAOsin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAOsin treatment<br>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<br>* DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month treatment with 1 month follow up | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food intolerance, histamine intolerance, diamine oxidase, DAO, DAOsin