An interventional study of Zeolite in Irritable Bowel Syndrome, Microbial Colonization and Intestinal Disease, sponsored by Scigenia GmbH. Completed at 1 site in Austria. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-24.
Sponsored by Scigenia GmbH · Not applicable, Interventional, and Treatment
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:
Further endpoints:
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.
4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.
This study's enrollment of 41 is below the median of 122 across 2,718 interventional studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →This is the only study on the registry with Scigenia GmbH as lead sponsor.
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Exclusion Criteria:
Zeolite, Medicinal product, class IIa for oral intake, daily intake of 2 sachets (3 g), for 3 months.
Other: Zeolite
Micro crystalline cellulose daily intake of 2 sachets (3 g), for 3 months.
Other: Zeolite
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.
Abdominal discomfort or pain
Frequency: 0 - never, 1 - less than once / month, 2 - once / month, 3 - two-three days / month, 4 - once per week, 5 - more than once per week, 6 - every day.
Time frame: 3 months
Symptom improvement with defaecation
0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.
Time frame: 3 months
Stool frequency associated with abdominal discomfort or pain (more or less frequent)
0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.
Time frame: 3 months
Stool consistency associated with abdominal discomfort or pain (softer or harder)
0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.
Time frame: 3 months
Stool laboratory parameter: Firmicutes
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Firmicutes (CFU/g stool)
Time frame: 3 months
Stool laboratory parameter: Bacteroidetes
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Bacteroidetes (CFU/g stool)
Time frame: 3 months
Stool laboratory parameter: Ratio: Bacteroidetes/Firmicutes
Genotyping of bacteria in stool, before and after intake of study substance; Computation of Ratio: Bacteroidetes/Firmicutes
Time frame: 3 months
Stool laboratory parameter: Butyrat Producers
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Butyratproducing bacteria (CFU/g stool)
Time frame: 3 months
Stool laboratory parameter: Clostridia
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Clostridia (CFU/g stool)
Time frame: 3 months
Stool laboratory parameter: Histaminproducers,
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Histaminproducing bacteria (CFU/g stool)
Time frame: 3 months
Stool laboratory parameter: H2S producers
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of H2S-producing bacteria (CFU/g stool)
Time frame: 3 months
Change of permeability (Leaky-Gut)
Zonulin (\< 55 ng/ml) in stool
Time frame: 3 months
Change of bowel inflammation
Calprotectin (\< 50 mg/l) in stool
Time frame: 3 months
Change of permeability of mucosa
Alpha 1-Antitrypsin (\< 27,5 mg/dl) in stool
Time frame: 3 months
Change of the inflammation mediator
Histamin (\< 600 ng/ml) in stool
Time frame: 3 months
Efficacy of binding and elimination of ammoniak
Ammoniak (11-51 µmol/l) in blood / serum
Time frame: 3 months
Change of inflammation
high sensitivity C-reactive protein (mg/l) in blood / serum
Time frame: 3 months
Change of anti-inflammatory mediator
Interleukin-10 (\< 9,1 pg/ml) in blood / serum
Time frame: 3 months
Possible release of metal ions
Aluminium (\< 11 µg/l) in blood / serum
Time frame: 3 months
Change of histamin metabolism
Di-Amino-Oxydase (\> 10 U/ml) in blood / serum
Time frame: 3 months
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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