Food Intolerance Clinical Trial
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
Verified date | September 2017 |
Source | Sciotec Diagnostic Technologies GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 16, 2018 |
Est. primary completion date | December 6, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Austria | Ordination für Innere Medizin und Stoffwechselzentrum | Bruck an der Mur |
Lead Sponsor | Collaborator |
---|---|
Sciotec Diagnostic Technologies GmbH |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Symptoms of histamine intolerance | Every proband documents the severity of histamine intolerance symptoms in a questionnaire. | 1 month with 1 month follow up | |
Secondary | Histamine level in plasma | Is the histamine level in plasma changing upon DAOsin treatment | 1 month with 1 month follow up | |
Secondary | Global assessment | Overall condition during study | 1 month with 1 month follow up |
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