PMA-Zeolite-Clinoptilolite Effects in Crohn Disease

Crohn Disease Clinical Trial

Official title:

Evaluation of PMA-Zeolite-Clinoptilolite Effects on the Dysbiosis and Inflammation in Patients With Uncontrolled Crohn Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04370535
• Other study ID #: crohn-disease ver. 1.3_17
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2018
• Est. completion date: May 15, 2020

Study information

• Verified date: May 2020
• Source: Ciim Plus, d.o.o.
• Contact: Krešimir Pavelic, Phd, M.D.
• Phone: + 385 98 247164
• Email: pavelic[@]unipu.hr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 15, 2020
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Slovenia	University Clinical Centre Ljubljana	Ljubljana
Slovenia	Medical Thermal Centre Fontana	Maribor
Slovenia	Slovenj Gradec General Hospital	Slovenj Gradec

Sponsors (2)

Lead Sponsor	Collaborator
Ciim Plus, d.o.o.	University of Rijeka

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	0(baseline) and after 12 weeks
Other	Rate of Safety and tolerability	Rate of tolerability and safety levels of minerals and metals	0(baseline) and after 12 weeks
Primary	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 .	0(baseline) and after 12 weeks
Secondary	Bacterial diversity in the marbus crohn patients	bactieria of assessment: Lactobacillus, Escherichia, bifidobacteria; Measurement: stool sample (16S RNA sequencing on stool sampling)	0(baseline) and after 12 weeks