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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|ClinicalTrials.gov Identifier: NCT03298568|
Recruitment Status : Completed
First Posted : October 2, 2017
Last Update Posted : April 17, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- Histamine level in plasma [ Time Frame: 1 month with 1 month follow up ]Is the histamine level in plasma changing upon DAOsin treatment
- Global assessment [ Time Frame: 1 month with 1 month follow up ]Overall condition during study
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 ClinicalTrials.gov identifier (NCT number): NCT03298568
|Ordination für Innere Medizin und Stoffwechselzentrum|
|Bruck an der Mur, Austria, 8600|