Crohn DiseaseNCT04370535
PMA-Zeolite-Clinoptilolite Effects in Crohn Disease
A study testing cellulose and PMA-zeolite in people with Crohn Disease, run by Ciim Plus, d.o.o. at 3 sites in Slovenia.
Trial 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-group (healthy volunteers) receiving either PMA-zeolite or placebo and the test-group (suffering from uncontrolled CD)… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- cellulose and PMA-zeolite
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesSlovenia
- Study dates
- 17 Oct 2018to 15 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Slovenia3 sites, 3 recruiting
- Recruiting
University Clinical Centre Ljubljana
Ljubljana, 1000
Joško Osredkar, Phd., M.D., 1 522 24 37 ext. + 386, josko.osredkar@kclj.si
- Recruiting
Medical Thermal Centre Fontana
Maribor, 2000
Željko Perdija, M.D., 2 23 44 102 ext. + 386, zdravstvo@termemb.si
- Recruiting
Slovenj Gradec General Hospital
Slovenj Gradec, 2380
Željko Perdija, M.D., 2 882 34 00 ext. +386, zeljko.perdija@gmail.com
About this study
Official title: Evaluation of PMA-Zeolite-Clinoptilolite Effects on the Dysbiosis and Inflammation in Patients With Uncontrolled Crohn Disease
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.
Read the 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 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.
- Conditions
- Crohn Disease
- Being tested
- cellulose, PMA-zeolite
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celluloseDevice
The subjects of group A and group C receive boxes containing placebo for supplementation for a total of 12 weeks.
PMA-zeoliteDevice
The subjects of group B and group D receive boxes containing PMA-zeolite for supplementation for a total of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group + cellulose (Group A) | Placebo comparator | healthy subjects (control group) receive placebo (cellulose) as powder Receives: Device: cellulose |
| Control group + PMA-zeolite(Group B) | Active comparator | healthy subjects (control group) receive PMA-zeolite as powder Receives: Device: PMA-zeolite |
| UCD-group + Cellulose (Group C) | Placebo comparator | subjects with uncontrolled Crohn disease (UCD group) receive placebo (cellulose) as powder Receives: Device: cellulose |
| UCD-group + PMA-zeolite (Group D) | Active comparator | subjects with uncontrolled Crohn disease receive PMA-zeolite as powder Receives: Device: PMA-zeolite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 0(baseline) and after 12 weeks
Secondary outcomes (1)
Bacterial diversity in the marbus crohn patients
bactieria of assessment: Lactobacillus, Escherichia, bifidobacteria
Measurement: stool sample (16S RNA sequencing on stool sampling)
Measured: 0(baseline) and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start17 Oct 2018
- Primary completion28 Nov 2019
- Study completion15 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The pilot-study is a randomized, placebo-controlled and double blinded study. The 4 subject-groups are consisting of group A and B with healthy subjects (A and B are divided into a placebo-group and into a PMA-zeolite- group) and group C and D which are subjects suffering from CD (C and D are divided into a placebo-group and into a PMA-zeolite- group). No washout phase is planned, but if food-supplements are taken this will be protocolled. The diagnostics will be performed through the defined parameters at defined time-points.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciim Plus, d.o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rijeka
- Responsible party
- Sponsor
- Investigators
- Krešimir Pavelić, PhD, M.D., Principal investigator, Juraj Dobrila University of Pula
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370535
- Sponsor's protocol ID
- crohn-disease ver. 1.3_17
- Status last verified
- May 2020
- First submitted
- 4 May 2018
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35712111
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PMA-Zeolite-Clinoptilolite Effects on the Dysbiosis and Inflammation in Patients With Uncontrolled Crohn Disease
- ClinicalTrials.gov ID
- NCT04370535
- Acronym / sponsor ID
- crohn-disease ver. 1.3_17
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ciim Plus, d.o.o.Industry (pharma, biotech, devices)
- Collaborators
- University of Rijeka
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- The pilot-study is a randomized, placebo-controlled and double blinded study. The 4 subject-groups are consisting of group A and B with healthy subjects (A and B are divided into a placebo-group and into a PMA-zeolite- group) and group C and D which are subjects suffering from CD (C and D are divided into a placebo-group and into a PMA-zeolite- group). No washout phase is planned, but if food-supplements are taken this will be protocolled. The diagnostics will be performed through the defined parameters at defined time-points.
| Arm | Type | Receives |
|---|---|---|
| Control group + cellulose (Group A) | Placebo comparator | Device: cellulosehealthy subjects (control group) receive placebo (cellulose) as powder |
| Control group + PMA-zeolite(Group B) | Active comparator | Device: PMA-zeolitehealthy subjects (control group) receive PMA-zeolite as powder |
| UCD-group + Cellulose (Group C) | Placebo comparator | Device: cellulosesubjects with uncontrolled Crohn disease (UCD group) receive placebo (cellulose) as powder |
| UCD-group + PMA-zeolite (Group D) | Active comparator | Device: PMA-zeolitesubjects with uncontrolled Crohn disease receive PMA-zeolite as powder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Signed informed consent as per usual recommendations in vigour in the Republic of Slovenia.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celluloseThe subjects of group A and group C receive boxes containing placebo for supplementation for a total of 12 weeks. | Device | Control group + cellulose (Group A), UCD-group + Cellulose (Group C) |
| PMA-zeoliteThe subjects of group B and group D receive boxes containing PMA-zeolite for supplementation for a total of 12 weeks. | Device | Control group + PMA-zeolite(Group B), UCD-group + PMA-zeolite (Group D) |
Primary outcome
Zonulin concentration in stool (ng/ml)
Time frame: 0(baseline) and after 12 weeks
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 .
1 secondary outcome
Bacterial diversity in the marbus crohn patients
Time frame: 0(baseline) and after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Derived from this study: PubMed 35712111Kraljevic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krešimir Pavelić, PhD, M.D. principal investigator
Juraj Dobrila University of Pula
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cellulose and PMA-zeolite in people with Crohn Disease, run by Ciim Plus, d.o.o. at 3 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krešimir Pavelić, Phd, M.D. (+ 385 98 247164, pavelic@unipu.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zonulin concentration in stool (ng/ml) (time frame: 0(baseline) and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04370535, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.