An interventional study of DAOsin in Food Intolerance and Histamine Intolerance, sponsored by Sciotec Diagnostic Technologies GmbH. Completed at 1 site in Austria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Sciotec Diagnostic Technologies GmbH · Not applicable, Interventional, and Treatment
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.
34 studies on the registry are indexed under Food Intolerance; 6 are open to participants now.
This study's enrollment of 30 is below the median of 58 across 27 interventional studies indexed under Food Intolerance.
Browse Food Intolerance studies →Sciotec Diagnostic Technologies GmbH is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake.
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.
Time frame: 1 month treatment with 1 month follow up
Symptoms of histamine intolerance
Every proband documents the severity of histamine intolerance symptoms in a questionnaire.
Time frame: 1 month with 1 month follow up
Histamine level in plasma
Is the histamine level in plasma changing upon DAOsin treatment
Time frame: 1 month with 1 month follow up
Global assessment
Overall condition during study
Time frame: 1 month with 1 month follow up
Ran from Aug 2017 to primary completion in Dec 2017, 3 months.
Of 21 interventional studies with no phase under Food Intolerance, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's 3 months is below that.
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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Sciotec Diagnostic Technologies GmbH