Panaceo "MED" for IBS (Irritable Bowel Syndrome)

Status Completed

Clinical Trial Summary

Zeolite clinoptilolite is a volcanic mineral from the group of zeolites. The porous structure is associated with a large inner surface. Due to the anionic framework charge, ions (e.g., Pb^2+) can be absorbed or exchanged. The specific Panaceo PMA zeolite is approved as a class IIa medical device for the repair of the intestine inner lining. It is CE certified and complies with the relevant European Union regulations in terms of safety and effectiveness. Zeolite is known for its absorbing properties. Because of these properties and the results of several human studies, it warrants the investigation of possible effects on specific indications in human medicine, e.g. irritable bowel syndrome. The diagnosis "irritable bowel syndrome (IBS)" is according to the ROME Foundation, an US medical society. IBS is a disorder with dysfunction of the bowels, a latent inflammation is discussed. The present study aims to evaluate the following effects in patients with IBS: - Primary endpoint: effect on the symptoms of IBS. - Secondary endpoint: intestinal wall permeability, integrity of the tight junctions as measured by the change in zonulin concentration in the stool. - Further endpoints: - Inflammation parameters and anti-inflammatory laboratory parameters. - Biodiversity of the gastrointestinal microbiome. - histamine-associated parameters. - Constipation as a possible side effect. For this purpose, a double-blind randomized controlled trial (RCT) is realized prospectively in a monocentric outpatient-controlled study. The subjects take the test compound daily (verum, reference substance) for 12 weeks and document the intake of the study-substance, intake of medications, stool-frequency and consistency. They receive "before" and "after" the intervention phase a blood and stool analysis for the determination of parameters for intestinal wall integrity (zonulin) inflammation (hsCRP, interleukin-10, calprotectin), histamine metabolism, microbiome diversity. The pilot study is realized ahead of the detailed planning of a later main study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03817645
Study type	Interventional
Source	Scigenia GmbH
Contact
Status	Completed
Phase	N/A
Start date	March 9, 2018
Completion date	June 30, 2020

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Panaceo "MED" for IBS (Irritable Bowel Syndrome) — PCeo-17

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms