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

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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome; Microbial Colonization; Intestinal Disease
• Intervention / Treatment: Other: Zeolite

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • SCIgenia GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panaceo MED; Zeolite, Medicinal product, class IIa for oral intake, 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.
Placebo Comparator: Control; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of permeability (Leaky-Gut)	Zonulin (< 55 ng/ml) in stool	3 months
Change of bowel inflammation	Calprotectin (< 50 mg/l) in stool	3 months
Change of permeability of mucosa	Alpha 1-Antitrypsin (< 27,5 mg/dl) in stool	3 months
Change of the inflammation mediator	Histamin (< 600 ng/ml) in stool	3 months
Efficacy of binding and elimination of ammoniak	Ammoniak (11-51 µmol/l) in blood / serum	3 months
Change of inflammation	high sensitivity C-reactive protein (mg/l) in blood / serum	3 months
Change of anti-inflammatory mediator	Interleukin-10 (< 9,1 pg/ml) in blood / serum	3 months
Possible release of metal ions	Aluminium (< 11 µg/l) in blood / serum	3 months
Change of histamin metabolism	Di-Amino-Oxydase (> 10 U/ml) in blood / serum	3 months

Collaborators and Investigators

• Sponsor: Scigenia GmbH
• Investigators: Principal Investigator: Ventzislav Petkov, M.D., Physician

Publications and helpful links

General Publications

• Lamprecht M, Bogner S, Steinbauer K, Schuetz B, Greilberger JF, Leber B, Wagner B, Zinser E, Petek T, Wallner-Liebmann S, Oberwinkler T, Bachl N, Schippinger G. Effects of zeolite supplementation on parameters of intestinal barrier integrity, inflammation, redoxbiology and performance in aerobically trained subjects. J Int Soc Sports Nutr. 2015 Oct 20;12:40. doi: 10.1186/s12970-015-0101-z. eCollection 2015.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Zeolite
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Syndrome; Irritable Bowel Syndrome; Infections; Communicable Diseases; Intestinal Diseases
• Other Study ID Numbers: PCeo-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No