Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2018-10-17
2020-05-15
Brief Summary
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Detailed Description
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Hypothesis In the present trial, it is being tested if supplementing PMA-zeolite can lead to an improvement of the defined markers and parameters (reduction of local and systemic inflammation, changes of the microbiota in the gut, positive detoxifying effect and general improvement of quality of life) in patients with uncontrolled CD compared to a healthy test-group.
Aims This pilot study aims to evaluate the safety and efficacy of PMA-zeolite when used in patients with uncontrolled CD. The effect of the PMA-zeolite will be compared between a control-group (healthy volunteers) receiving either PMA-zeolite or placebo and the test-group (suffering from uncontrolled CD) and receiving either PMA-zeolite or placebo. In addition, this pilot-study should furthermore provide indications for the effect-size in order to estimate an effect for an eventual further human trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group + cellulose (Group A)
healthy subjects (control group) receive placebo (cellulose) as powder
cellulose
The subjects of group A and group C receive boxes containing placebo for supplementation for a total of 12 weeks.
Control group + PMA-zeolite(Group B)
healthy subjects (control group) receive PMA-zeolite as powder
PMA-zeolite
The subjects of group B and group D receive boxes containing PMA-zeolite for supplementation for a total of 12 weeks.
UCD-group + Cellulose (Group C)
subjects with uncontrolled Crohn disease (UCD group) receive placebo (cellulose) as powder
cellulose
The subjects of group A and group C receive boxes containing placebo for supplementation for a total of 12 weeks.
UCD-group + PMA-zeolite (Group D)
subjects with uncontrolled Crohn disease receive PMA-zeolite as powder
PMA-zeolite
The subjects of group B and group D receive boxes containing PMA-zeolite for supplementation for a total of 12 weeks.
Interventions
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cellulose
The subjects of group A and group C receive boxes containing placebo for supplementation for a total of 12 weeks.
PMA-zeolite
The subjects of group B and group D receive boxes containing PMA-zeolite for supplementation for a total of 12 weeks.
Eligibility Criteria
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Inclusion Criteria
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.
* Signed informed consent as per usual recommendations in vigour in the Republic of Slovenia.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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University of Rijeka
OTHER
Ciim Plus, d.o.o.
INDUSTRY
Responsible Party
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Principal Investigators
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Krešimir Pavelić, PhD, M.D.
Role: PRINCIPAL_INVESTIGATOR
Juraj Dobrila University of Pula
Locations
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University Clinical Centre Ljubljana
Ljubljana, , Slovenia
Medical Thermal Centre Fontana
Maribor, , Slovenia
Slovenj Gradec General Hospital
Slovenj Gradec, , Slovenia
Countries
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Central Contacts
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Facility Contacts
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References
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Kraljevic Pavelic S, Saftic Martinovic L, Simovic Medica J, Zuvic M, Perdija Z, Krpan D, Eisenwagen S, Orct T, Pavelic K. Clinical Evaluation of a Defined Zeolite-Clinoptilolite Supplementation Effect on the Selected Blood Parameters of Patients. Front Med (Lausanne). 2022 May 27;9:851782. doi: 10.3389/fmed.2022.851782. eCollection 2022.
Other Identifiers
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crohn-disease ver. 1.3_17
Identifier Type: -
Identifier Source: org_study_id
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