PMA-Zeolite-Clinoptilolite Effects in Crohn Disease

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04370535

crohn-disease ver. 1.3_17

Ages 18-65
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Healthy volunteers (at least 18 years old) for first two groups (A,B), homogenousstarting 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 treatedwith standard therapy and despite of treatment do not achieve the appropriate diseaseremission. Patients with the intermediate type of disease will be also included ingroups C and D.
Diagnosis has to be confirmed with a biopsy of the intestine and histologicalexam.
Degree of disease will be assessed by Harvey-Bradshaw Index (HBI). For evaluationof quality BDQ questionnaire will be used. For the assessment of disease activityordinary laboratory measurements will be performed (CBC, basic biochemicalparameters, CRP), and calprotectin from chairs. Colonoscopy must be done in thelast six months prior to inclusion of patients in the research protocol.Gastrointestinal system degree of impairment will not have influence on inclusioncriteria and patients with histological intermediate type of disease will beincluded as well.
Signed informed consent as per usual recommendations in vigour in the Republic ofSlovenia.

Exclusion

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 becontinued also during the study and documented - otherwise a wash - out - phase wouldbe necessary

Study Design

October 17, 2018

May 15, 2020

Study 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.

Connect with a study center

University Clinical Centre Ljubljana
Ljubljana, 1000
Slovenia
Active - Recruiting
Medical Thermal Centre Fontana
Maribor, 2000
Slovenia
Active - Recruiting
Slovenj Gradec General Hospital
Slovenj Gradec, 2380
Slovenia
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.