Food Intolerance, Histamine Intolerance
Conditions
Keywords
food intolerance, histamine intolerance, diamine oxidase, DAO, DAOsin
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTDAOsin
DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake.
Sponsors
Sciotec Diagnostic Technologies GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline activity of diamine oxidase activity in serum | 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
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of histamine intolerance | 1 month with 1 month follow up | Every proband documents the severity of histamine intolerance symptoms in a questionnaire. |
| Histamine level in plasma | 1 month with 1 month follow up | Is the histamine level in plasma changing upon DAOsin treatment |
| Global assessment | 1 month with 1 month follow up | Overall condition during study |
Countries
Austria
Outcome results
None listed