CompletedNCT03298568Updated Apr 17, 2018

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

An interventional study of DAOsin in Food Intolerance and Histamine Intolerance, sponsored by Sciotec Diagnostic Technologies GmbH. Completed at 1 site in Austria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-17.

Sponsored by Sciotec Diagnostic Technologies GmbH · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Food Intolerance
Histamine Intolerance

Browse trials for

Food Intolerance 22

Keywords

food intolerance
histamine intolerance
diamine oxidase
DAO
DAOsin

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts 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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

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

Interventions

Dietary supplementDAOsin
DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake.

What researchers measure

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.
Time frame: 1 month with 1 month follow up
Histamine level in plasma
Is the histamine level in plasma changing upon DAOsin treatment
Time frame: 1 month with 1 month follow up
Global assessment
Overall condition during study
Time frame: 1 month with 1 month follow up

Study locations

1 site

Ordination für Innere Medizin und Stoffwechselzentrum
Bruck an der Mur, 8600, Austria

References and documents

Publications

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. PubMed 31807350 ↗

Registry details

Key details

Study ID: NCT03298568
Lead sponsor: Sciotec Diagnostic Technologies GmbH
Responsible party: Sponsor
First posted: Oct 2, 2017
Start date: Aug 21, 2017
Primary completion: Dec 6, 2017
Completion: Apr 16, 2018
Last update: Apr 17, 2018

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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