Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT03298568
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03298568
Study Brief:
Protocol Section:
NCT03298568