Panaceo MED for IBS (Irritable Bowel Syndrome)

Study Overview
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Brief Summary
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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.

Official Title
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Pilot-trial on the Use of the Panaceo Medicine Product MED for the Treatment of IBS (Irritable Bowel Syndrome)

Conditions
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Irritable Bowel Syndrome, Microbial Colonization, Intestinal Disease

Intervention / Treatment
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* Other: Zeolite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Frequency of discomfort or pain in the abdomen in the last 3 months, more than 1 day per week. Start of the discomfort or pain more than 6 months ago. Improvement of the discomfort or pain associated with bowel movements sometimes, often, frequently, always. Association of the discomfort or pain with a frequency change in bowel movements sometimes, often, frequently, always. Association of the discomfort or pain with a change in stool-consistency sometimes, often, frequently, always. Exclusion Criteria: Age: younger than 18, older than 80. Diagnosed inflammatory bowel disease (M. Crohn, Colitis Ulcerosa) Diagnosed nutritional idiosyncrasy Cancer treatment in the last 12 weeks Depression in the last 12 weeks Intake of weight loss supporting medication (Lipase inhibitors) Alcohol, nicotine, drug-abuse Status after organ-transplantation, intake of immunosuppressants Acute or chronic neurologic or psychiatric disease Acute or chronic heart disease or kidney disease Acute or chronic liver damage or any other organ damages Transient severe obstipation in the last 4 weeks Transient acute diarrhea in the last 4 weeks (e.g. intestinal infection) Intestinal cancer Intake of Panaceo MED or other Zeolite in the last 4 weeks Type I Diabetes or severe metabolic disease Infection with fever in the last 4 weeks Intake of cortisone or antibiotics in the last 4 weeks Planed journey of more than 14 days in the next 12 weeks (change of nutritional habits)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panaceo MED<br>Zeolite, Medicinal product, class IIa for oral intake, daily intake of 2 sachets (3 g), for 3 months. | Other: Zeolite<br>* 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.<br>|
| Placebo Comparator: Control<br>Micro crystalline cellulose daily intake of 2 sachets (3 g), for 3 months. | Other: Zeolite<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 
| Symptom improvement with defaecation | 0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always. | 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. | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool laboratory parameter: Firmicutes | Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Firmicutes (CFU/g stool) | 3 months | 
| Stool laboratory parameter: Bacteroidetes | Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Bacteroidetes (CFU/g stool) | 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 | 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) | 3 months | 
| Stool laboratory parameter: Clostridia | Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Clostridia (CFU/g stool) | 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) | 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) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zeolite