Sciotec Diagnostic Technologies GmbH

Fructosin® is a medical device for use in fructose intolerance. In this uncontrolled posdt market clinical follow up (PMCF) study, the safety and efficacy of oral supplementation of Fructosin® in fructose intolerance will be investigated.
The study participants will be informed about the nature and scope of the study during a preliminary examination (screening) and a declaration of consent will be obtained. In addition, it is determined whether fructose intolerance is present. This is determined by means of the aCPQ test. Subsequently, the patients fill out symptom questionnaires (IBS-SSS, IBS-QoL, 1-week symptom questionnaire).
After the eligibility check, a 14-day phase of monitoring and documentation of symptoms and complaints without taking Fructosin® (observation phase) takes place. At visit 1, the patients receive the Fructosin® capsules, which they take as needed, but no more than 2 x 3 times a day with fruit meals. The intake phase runs over a period of 28 days (4 weeks) during which the study participants observe and evaluate gastrointestinal symptoms with the help of the 1-weekly symptom questionnaire. In addition, the daily fructose consumption (fruit, fruit juices, smoothies) and the amount of Fructosin® capsules taken are documented in a diary.

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.

This study aims to define a provocation test for histamine intolerance (aka. biogenic amine intolerance syndrome) and test the capability of an oral enzyme supplementation to ameliorate this condition.