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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03298568
• Other study ID #: BTS1077/17
• Status: Completed
• Phase: N/A
• First received: September 26, 2017
• Last updated: April 16, 2018
• Start date: August 21, 2017
• Est. completion date: April 16, 2018

Study information

• Verified date: September 2017
• Source: Sciotec Diagnostic Technologies GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Food Intolerance
• Histamine Intolerance

Intervention

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

Locations

Country	Name	City	State
Austria	Ordination für Innere Medizin und Stoffwechselzentrum	Bruck an der Mur

Sponsors (1)

Lead Sponsor	Collaborator
Sciotec Diagnostic Technologies GmbH

Country where clinical trial is conducted

Austria, 

Outcome

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