Clinical trial NCT03298568: Study to Investigate the Effect of an Oral Diamine Oxidase Substitution (DAOsin) in Histamine Intolerant Patients on the Low Endogenous Diamine Oxidase Serum Activity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Intolerance
Histamine Intolerance
Keywords: food intolerance
histamine intolerance
diamine oxidase
DAO
DAOsin
Lead sponsor: Sciotec Diagnostic Technologies GmbH
Sponsor class: INDUSTRY
First posted: 2017-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in baseline activity of diamine oxidase activity in serum
timeFrame: 1 month treatment with 1 month follow up
Secondary outcomes:
measure: Symptoms of histamine intolerance
timeFrame: 1 month with 1 month follow up
measure: Histamine level in plasma
timeFrame: 1 month with 1 month follow up
measure: Global assessment
timeFrame: 1 month with 1 month follow up
Other outcomes:
Locations:
city: Bruck an der Mur
country: Austria
facility: Ordination für Innere Medizin und Stoffwechselzentrum
Study officials:
References:
citation: 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.