Status:
UNKNOWN
PMA-Zeolite-Clinoptilolite Effects in Crohn Disease
Lead Sponsor:
Ciim Plus, d.o.o.
Collaborating Sponsors:
University of Rijeka
Conditions:
Crohn Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This pilot study aims to evaluate the safety and efficacy of PMA-zeolite when used in patients with uncontrolled CD (Crohn´s disease). The effect of the PMA-zeolite will be compared between a control-...
Detailed Description
Background of the study Crohn´s disease (CD) is a chronic progressive destructive disease. Approximately one-fifth of adult and paediatric patients already have evidence of a structuring or penetratin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04370535
Start Date
October 17 2018
End Date
May 15 2020
Last Update
May 20 2020
Active Locations (3)
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1
University Clinical Centre Ljubljana
Ljubljana, Slovenia, 1000
2
Medical Thermal Centre Fontana
Maribor, Slovenia, 2000
3
Slovenj Gradec General Hospital
Slovenj Gradec, Slovenia, 2380