An interventional study of cellulose and PMA-zeolite in Crohn Disease, sponsored by Ciim Plus, d.o.o.. Status unknown at 3 sites in Slovenia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-20.
Sponsored by Ciim Plus, d.o.o. · Not applicable, Interventional, and Treatment
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-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.
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 penetrating intestinal complications at diagnosis. Despite decades of research, the aetiology of CD remains unknown. Disease treatments include a variety of approaches like dietary changes and immunosuppressive anti-TNFa antibodies as well as ancillary antibiotic therapy. Another interesting and promising approach in this context might be the supplementation of the certified medical device PMA-(Panaceo micro activation)-zeolite (a specific natural zeolite-clinoptilolite) due to its properties documented through many studies. In particular, the promising clinical results from a randomized controlled trial (RCT) with PMA-zeolite need to be highlighted. The strengthening/ supporting of the intestinal wall integrity in healthy subjects suffering from intestinal problems was measured in this RCT and is claimed as intended main action of the PMA-zeolite. Based on these results the application of PMA-zeolite is an interesting and promising approach in patients with uncontrolled CD.
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →This is the only study on the registry with Ciim Plus, d.o.o. as lead sponsor.
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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.
Exclusion Criteria:
healthy subjects (control group) receive placebo (cellulose) as powder
Device: cellulose
healthy subjects (control group) receive PMA-zeolite as powder
Device: PMA-zeolite
subjects with uncontrolled Crohn disease (UCD group) receive placebo (cellulose) as powder
Device: cellulose
subjects with uncontrolled Crohn disease receive PMA-zeolite as powder
Device: PMA-zeolite
The subjects of group A and group C receive boxes containing placebo for supplementation for a total of 12 weeks.
The subjects of group B and group D receive boxes containing PMA-zeolite for supplementation for a total of 12 weeks.
Zonulin concentration in stool (ng/ml)
As the intestinal wall permeability is linked to several conditions, such as the Crohn Disease it is hypothesized that a change of Zonulin (biomarker for permeability of intestinal wall) is detectable with/without supplementation of the study-substance. Measurement: stool stool sample (by ELISA kit) Standard Value for Zonulin: \< 55 ng/ml .
Time frame: 0(baseline) and after 12 weeks
Bacterial diversity in the marbus crohn patients
bactieria of assessment: Lactobacillus, Escherichia, bifidobacteria Measurement: stool sample (16S RNA sequencing on stool sampling)
Time frame: 0(baseline) and after 12 weeks
Changes of blood parameters
Blood samples for measurement of definied parameters: * Ni: 0,6-3,8 µg/L * Al: \< 7,0 µg/L * Na: 3100,0 - 3350,0 mg/L * K: 140,0 - 200,0 mg/L * Mg: 17,0-23,0 mg/L * Ca: 89,0-101,0 mg/L * Se: 70,0-150,0 µg/L * Zn: 660,0-1100,0 µg/L * Cu: 750,0-1450,0 µg/L * Fe: M: 550,0-1600,0 µg/L * F: 400,0-1550,0 µg/L DAO (Standard Value \> 10 U/ml ), ammonia - µmol/l,histamine (ng/ml), Measurement of sedimentation, blood count, electrolytes, urea, liver-parameters, creatinine and other
Time frame: 0(baseline) and after 12 weeks
Rate of Safety and tolerability
Rate of tolerability and safety levels of minerals and metals
Time frame: 0(baseline) and after 12 weeks
Plan to share: No
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