Study to Investigate the Effect of an Oral Diamine Oxidase Substitution (DAOsin) in Histamine Intolerant Patients on the Low Endogenous Diamine Oxidase Serum Activity

Sciotec Diagnostic Technologies GmbH30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Food Intolerance Histamine Intolerance

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 month treatment with 1 month follow up

Secondary Outcomes

Symptoms of histamine intolerance

Every proband documents the severity of histamine intolerance symptoms in a questionnaire.