Study to Investigate the Effect of an Oral Diamine Oxidase Substitution (DAOsin) in Histamine Int… (NCT03298568) | Clinical Trial Compass
CompletedNot Applicable
Study to Investigate the Effect of an Oral Diamine Oxidase Substitution (DAOsin) in Histamine Intolerant Patients on the Low Endogenous Diamine Oxidase Serum Activity
Austria30 participantsStarted 2017-08-21
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in baseline activity of diamine oxidase activity in serum
Timeframe: 1 month treatment with 1 month follow up