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Food IntoleranceNCT03298568

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

A study testing DAOsin in people with Food Intolerance and Histamine Intolerance, run by Sciotec Diagnostic Technologies GmbH at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Food Intolerance, Histamine Intolerance
What is being tested?
DAOsin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteAustria
Study dates
21 Aug 2017to 16 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • pregnancy and nursing
  • cardiopathy
  • instable hypertonie
  • asthma bronchial
  • lactose intolerance, fructose intolerance, coeliac disease
  • severe liver and kidney diseases
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Ordination für Innere Medizin und Stoffwechselzentrum

    Bruck an der Mur, 8600

Other trials in Austria

About this study

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

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.

Being tested
DAOsin
Keywords
food intolerance, histamine intolerance, diamine oxidase, DAO, DAOsin
Medical subject headings
Food Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DAOsinDietary supplement

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

Study groups in NCT03298568
Study groupRoleWhat they receive
DAOsin treatmentExperimentalPatients suffering from histamine intolerance and a diamin oxidase activity below 10 Units/ml get a DAOsin treatment for one month 3 times a day.
Receives: Dietary Supplement: DAOsin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 month treatment with 1 month follow up

Secondary outcomes (3)

  1. Symptoms of histamine intolerance

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

    Measured: 1 month with 1 month follow up

  2. Histamine level in plasma

    Is the histamine level in plasma changing upon DAOsin treatment

    Measured: 1 month with 1 month follow up

  3. Global assessment

    Overall condition during study

    Measured: 1 month with 1 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start21 Aug 2017
  3. Primary completion6 Dec 2017
  4. Study completion16 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298568
Sponsor's protocol ID
BTS1077/17
Status last verified
Sep 2017
First submitted
26 Sep 2017
Last updated
17 Apr 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing DAOsin in people with Food Intolerance and Histamine Intolerance, run by Sciotec Diagnostic Technologies GmbH at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in baseline activity of diamine oxidase activity in serum (time frame: 1 month treatment with 1 month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03298568, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.

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