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

Sponsor

Scigenia GmbH (Other)

Overall Status

Completed

CT.gov ID

NCT03817645

Collaborator

(none)

Enrollment

Location

Arms

27.7

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome Microbial Colonization Intestinal Disease	Other: Zeolite	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 9, 2018

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Abdominal discomfort or pain [3 months]
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.
Symptom improvement with defaecation [3 months]
0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.
Stool frequency associated with abdominal discomfort or pain (more or less frequent) [3 months]
0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.
Stool consistency associated with abdominal discomfort or pain (softer or harder) [3 months]
0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.

Secondary Outcome Measures

Stool laboratory parameter: Firmicutes [3 months]
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Firmicutes (CFU/g stool)
Stool laboratory parameter: Bacteroidetes [3 months]
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Bacteroidetes (CFU/g stool)
Stool laboratory parameter: Ratio: Bacteroidetes/Firmicutes [3 months]
Genotyping of bacteria in stool, before and after intake of study substance; Computation of Ratio: Bacteroidetes/Firmicutes
Stool laboratory parameter: Butyrat Producers [3 months]
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Butyratproducing bacteria (CFU/g stool)
Stool laboratory parameter: Clostridia [3 months]
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Clostridia (CFU/g stool)
Stool laboratory parameter: Histaminproducers, [3 months]
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Histaminproducing bacteria (CFU/g stool)
Stool laboratory parameter: H2S producers [3 months]
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of H2S-producing bacteria (CFU/g stool)

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)