Status:
COMPLETED
Study to Investigate the Effect of an Oral Diamine Oxidase Substitution (DAOsin) in Histamine Intolerant Patients on the Low Endogenous Diamine Oxidase Serum Activity
Lead Sponsor:
Sciotec Diagnostic Technologies GmbH
Conditions:
Food Intolerance
Histamine Intolerance
Eligibility:
All Genders
18-80 years
Phase:
NA
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 diami...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03298568
Start Date
August 21 2017
End Date
April 16 2018
Last Update
April 17 2018
Active Locations (1)
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1
Ordination für Innere Medizin und Stoffwechselzentrum
Bruck an der Mur, Austria, 8600