PMA-Zeolite-Clinoptilolite Effects in Crohn Disease

NCT04370535 | Unknown

• 1 other identifier: crohn-disease ver. 1.3_17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bacterial diversity in the marbus crohn patients

  0(baseline) and after 12 weeks

Other Outcomes (2)

• Changes of blood parameters

  0(baseline) and after 12 weeks

• Rate of Safety and tolerability

  0(baseline) and after 12 weeks

Study Arms (4)

Control group + cellulose (Group A)

PLACEBO COMPARATOR

healthy subjects (control group) receive placebo (cellulose) as powder

Device: cellulose

Control group + PMA-zeolite(Group B)

ACTIVE COMPARATOR

healthy subjects (control group) receive PMA-zeolite as powder

Device: PMA-zeolite

UCD-group + Cellulose (Group C)

PLACEBO COMPARATOR

subjects with uncontrolled Crohn disease (UCD group) receive placebo (cellulose) as powder

Device: cellulose

UCD-group + PMA-zeolite (Group D)

ACTIVE COMPARATOR

subjects with uncontrolled Crohn disease receive PMA-zeolite as powder

Device: PMA-zeolite

Interventions

cellulose DEVICE

The subjects of group A and group C receive boxes containing placebo for supplementation for a total of 12 weeks.

Control group + cellulose (Group A); UCD-group + Cellulose (Group C)

PMA-zeolite DEVICE

The subjects of group B and group D receive boxes containing PMA-zeolite for supplementation for a total of 12 weeks.

Control group + PMA-zeolite(Group B); UCD-group + PMA-zeolite (Group D)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Signed informed consent as per usual recommendations in vigour in the Republic of Slovenia.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciim Plus, d.o.o.: lead
• University of Rijeka: collaborator

Study Sites (3)

University Clinical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Medical Thermal Centre Fontana

Maribor, 2000, Slovenia

RECRUITING

Slovenj Gradec General Hospital

Slovenj Gradec, 2380, Slovenia

RECRUITING

Related Publications (1)

• 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.

  PMID: 35712111 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Krešimir Pavelić, PhD, M.D.

  Juraj Dobrila University of Pula

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krešimir Pavelić, Phd, M.D.

CONTACT

+ 385 98 247164; pavelic@unipu.hr

Sandra Kraljević Pavelić, Phd

CONTACT

51 584569; sandrakp@uniri.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 1, 2020
• Study Start: October 17, 2018
• Primary Completion: November 28, 2019
• Study Completion: May 15, 2020
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

SL (3)