Panaceo "MED" for IBS (Irritable Bowel Syndrome)

Irritable Bowel Syndrome Clinical Trial

— PCeo-17  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817645
• Other study ID #: PCeo-17
• Status: Completed
• Phase: N/A
• Start date: March 9, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2021
• Source: Scigenia GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Intestinal Disease
• Intestinal Diseases
• Irritable Bowel Syndrome
• Microbial Colonization
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Austria	SCIgenia GmbH	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Scigenia GmbH

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of permeability (Leaky-Gut)	Zonulin (< 55 ng/ml) in stool	3 months
Other	Change of bowel inflammation	Calprotectin (< 50 mg/l) in stool	3 months
Other	Change of permeability of mucosa	Alpha 1-Antitrypsin (< 27,5 mg/dl) in stool	3 months
Other	Change of the inflammation mediator	Histamin (< 600 ng/ml) in stool	3 months
Other	Efficacy of binding and elimination of ammoniak	Ammoniak (11-51 µmol/l) in blood / serum	3 months
Other	Change of inflammation	high sensitivity C-reactive protein (mg/l) in blood / serum	3 months
Other	Change of anti-inflammatory mediator	Interleukin-10 (< 9,1 pg/ml) in blood / serum	3 months
Other	Possible release of metal ions	Aluminium (< 11 µg/l) in blood / serum	3 months
Other	Change of histamin metabolism	Di-Amino-Oxydase (> 10 U/ml) in blood / serum	3 months
Primary	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
Primary	Symptom improvement with defaecation	0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.	3 months
Primary	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
Primary	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	Stool laboratory parameter: Firmicutes	Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Firmicutes (CFU/g stool)	3 months
Secondary	Stool laboratory parameter: Bacteroidetes	Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Bacteroidetes (CFU/g stool)	3 months
Secondary	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
Secondary	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
Secondary	Stool laboratory parameter: Clostridia	Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Clostridia (CFU/g stool)	3 months
Secondary	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
Secondary	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