PMA-Zeolite-Clinoptilolite Effects in Crohn Disease
Crohn Disease
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers (at least 18 years old) for first two groups (A,B), homogenous starting group in age (30-60Y) and sex (m/f )
o The health-status will be confirmed through anamnesis.
Groups C and D will include patients with confirmed Crohn's disease that are treated with standard therapy and despite of treatment do not achieve the appropriate disease remission. Patients with the intermediate type of disease will be also included in groups C and D.
- Diagnosis has to be confirmed with a biopsy of the intestine and histological exam.
- Degree of disease will be assessed by Harvey-Bradshaw Index (HBI). For evaluation of quality BDQ questionnaire will be used. For the assessment of disease activity ordinary laboratory measurements will be performed (CBC, basic biochemical parameters, CRP), and calprotectin from chairs. Colonoscopy must be done in the last six months prior to inclusion of patients in the research protocol. Gastrointestinal system degree of impairment will not have influence on inclusion criteria and patients with histological intermediate type of disease will be included as well.
- Signed informed consent as per usual recommendations in vigour in the Republic of Slovenia.
Exclusion Criteria:
- Signs of acute bacterial infection (fever >38°C, nausea, vomiting).
- Other chronic disease (cancer, renal disease, neuro-degenerative, metabolic disorders, diabetic).
- Pregnancy or breastfeeding
- Food supplements** **NOTE: Food supplements: if taken regularly this should be continued also during the study and documented - otherwise a wash - out - phase would be necessary
Sites / Locations
- University Clinical Centre LjubljanaRecruiting
- Medical Thermal Centre FontanaRecruiting
- Slovenj Gradec General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Control group + cellulose (Group A)
Control group + PMA-zeolite(Group B)
UCD-group + Cellulose (Group C)
UCD-group + PMA-zeolite (Group D)
healthy subjects (control group) receive placebo (cellulose) as powder
healthy subjects (control group) receive PMA-zeolite as powder
subjects with uncontrolled Crohn disease (UCD group) receive placebo (cellulose) as powder
subjects with uncontrolled Crohn disease receive PMA-zeolite as powder