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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAOsin treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAOsin | Dietary Supplement | DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordination für Innere Medizin und Stoffwechselzentrum | Bruck an der Mur | 8600 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31807350 | Derived | 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. |
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| 1 month with 1 month follow up |
| Global assessment | Overall condition during study | 1 month with 1 month follow up |
| ID | Term |
|---|---|
| D000073923 | Food Intolerance |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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