NCT03298568

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2018

Completed
Last Updated

April 17, 2018

Status Verified

September 1, 2017

Enrollment Period

4 months

First QC Date

September 26, 2017

Last Update Submit

April 16, 2018

Conditions

Food IntoleranceHistamine Intolerance

Keywords

food intolerancehistamine intolerancediamine oxidaseDAODAOsin

Outcome Measures

Primary Outcomes (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.

    1 month treatment with 1 month follow up

Secondary Outcomes (3)

  • Symptoms of histamine intolerance

    1 month with 1 month follow up

  • Histamine level in plasma

    1 month with 1 month follow up

  • Global assessment

    1 month with 1 month follow up

Study Arms (1)

DAOsin treatment

EXPERIMENTAL

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

DAOsinDIETARY_SUPPLEMENT

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

DAOsin treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diamine oxidase activity \< 10 U/ml
  • \>= 2 symptoms of histamine intolerance after consumption of histamine containing food
  • to 80 years
  • no lactose intolerance
  • no fructose intolerance
  • no tissue transglutaminase antibodies in serum

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordination für Innere Medizin und Stoffwechselzentrum

Bruck an der Mur, 8600, Austria

Location

Related Publications (1)

  • 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.

    PMID: 31807350DERIVED

MeSH Terms

Conditions

Food Intolerance

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 2, 2017

Study Start

August 21, 2017

Primary Completion

December 6, 2017

Study Completion

April 16, 2018

Last Updated

April 17, 2018

Record last verified: 2017-09

Locations

AU(1)