Panaceo "MED" for IBS (Irritable Bowel Syndrome)
Condition: Irritable Bowel Syndrome; Microbial Colonization; Intestinal Disease
MeSH terms: Communicable Diseases; Infections; Irritable Bowel Syndrome; Intestinal Diseases; Syndrome
Study type: Interventional

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.
    


Intervention name(s): Zeolite
Intervention type(s): Other
Intervention description(s): The natural zeolite clinoptilolite is of volcanic origin. The mineral belongs to the group of zeolite minerals. Zeolites are silicates with a microporous structure. This results in a stable structure with nanometer-sized cavities that pass through the natural zeolite clinoptilolite - comparable to a mineral sponge. Due to the numerous pores and channels, the mineral has a large internal surface and it can absorb molecules that are smaller in diameter than the pore openings. Since zeolite clinoptilolite has an anionic charge, there are cations such as Na +, K +, Ca 2+, Mg 2+ which can be exchanged for other ions (e.g., Pb^2+) in the cavities for electrical charge balance. In particular, the ion exchange capacity is essential for the effect and is used in many areas.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Zeolite