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

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ClinicalTrials.gov Identifier: NCT03817645
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Scigenia GmbH

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 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 : March 9, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

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.




Primary Outcome Measures :
  1. Abdominal discomfort or pain [ Time Frame: 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.

  2. Symptom improvement with defaecation [ Time Frame: 3 months ]
    0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.

  3. Stool frequency associated with abdominal discomfort or pain (more or less frequent) [ Time Frame: 3 months ]
    0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.

  4. Stool consistency associated with abdominal discomfort or pain (softer or harder) [ Time Frame: 3 months ]
    0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.


Secondary Outcome Measures :
  1. Stool laboratory parameter: Firmicutes [ Time Frame: 3 months ]
    Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Firmicutes (CFU/g stool)

  2. Stool laboratory parameter: Bacteroidetes [ Time Frame: 3 months ]
    Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Bacteroidetes (CFU/g stool)

  3. Stool laboratory parameter: Ratio: Bacteroidetes/Firmicutes [ Time Frame: 3 months ]
    Genotyping of bacteria in stool, before and after intake of study substance; Computation of Ratio: Bacteroidetes/Firmicutes

  4. Stool laboratory parameter: Butyrat Producers [ Time Frame: 3 months ]
    Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Butyratproducing bacteria (CFU/g stool)

  5. Stool laboratory parameter: Clostridia [ Time Frame: 3 months ]
    Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Clostridia (CFU/g stool)

  6. Stool laboratory parameter: Histaminproducers, [ Time Frame: 3 months ]
    Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Histaminproducing bacteria (CFU/g stool)

  7. Stool laboratory parameter: H2S producers [ Time Frame: 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:
  1. Change of permeability (Leaky-Gut) [ Time Frame: 3 months ]
    Zonulin (< 55 ng/ml) in stool

  2. Change of bowel inflammation [ Time Frame: 3 months ]
    Calprotectin (< 50 mg/l) in stool

  3. Change of permeability of mucosa [ Time Frame: 3 months ]
    Alpha 1-Antitrypsin (< 27,5 mg/dl) in stool

  4. Change of the inflammation mediator [ Time Frame: 3 months ]
    Histamin (< 600 ng/ml) in stool

  5. Efficacy of binding and elimination of ammoniak [ Time Frame: 3 months ]
    Ammoniak (11-51 µmol/l) in blood / serum

  6. Change of inflammation [ Time Frame: 3 months ]
    high sensitivity C-reactive protein (mg/l) in blood / serum

  7. Change of anti-inflammatory mediator [ Time Frame: 3 months ]
    Interleukin-10 (< 9,1 pg/ml) in blood / serum

  8. Possible release of metal ions [ Time Frame: 3 months ]
    Aluminium (< 11 µg/l) in blood / serum

  9. Change of histamin metabolism [ Time Frame: 3 months ]
    Di-Amino-Oxydase (> 10 U/ml) in blood / serum



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817645


Contacts
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Contact: Wilhelm Mosgoeller, M.D. +43 664 2848324 wm@scigenia.com
Contact: Monika Schein +4312392323 fides@scigenia.com

Locations
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Austria
SCIgenia GmbH Recruiting
Vienna, Austria, 1090
Contact: Wilhelm Mosgoeller, M.D.    +436642848324    wm@scigenia.com   
Sponsors and Collaborators
Scigenia GmbH
Investigators
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Principal Investigator: Ventzislav Petkov, M.D. Physician

Publications:
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Responsible Party: Scigenia GmbH
ClinicalTrials.gov Identifier: NCT03817645     History of Changes
Other Study ID Numbers: PCeo-17
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Scigenia GmbH:
Zeolite

Additional relevant MeSH terms:
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Communicable Diseases
Infection
Syndrome
Irritable Bowel Syndrome
Intestinal Diseases
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Gastrointestinal Diseases
Digestive System Diseases