<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03817645</url>
  </required_header>
  <id_info>
    <org_study_id>PCeo-17</org_study_id>
    <nct_id>NCT03817645</nct_id>
  </id_info>
  <brief_title>Panaceo &quot;MED&quot; for IBS (Irritable Bowel Syndrome)</brief_title>
  <acronym>PCeo-17</acronym>
  <official_title>Pilot-trial on the Use of the Panaceo Medicine Product &quot;MED&quot; for the Treatment of IBS (Irritable Bowel Syndrome)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scigenia GmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Scigenia GmbH</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Zeolite clinoptilolite is a volcanic mineral from the group of zeolites. The porous structure&#xD;
      is associated with a large inner surface. Due to the anionic framework charge, ions (e.g.,&#xD;
      Pb^2+) can be absorbed or exchanged. The specific Panaceo PMA zeolite is approved as a class&#xD;
      IIa medical device for the repair of the intestine inner lining. It is CE certified and&#xD;
      complies with the relevant European Union regulations in terms of safety and effectiveness.&#xD;
      Zeolite is known for its absorbing properties. Because of these properties and the results of&#xD;
      several human studies, it warrants the investigation of possible effects on specific&#xD;
      indications in human medicine, e.g. irritable bowel syndrome.&#xD;
&#xD;
      The diagnosis &quot;irritable bowel syndrome (IBS)&quot; is according to the ROME Foundation, an US&#xD;
      medical society. IBS is a disorder with dysfunction of the bowels, a latent inflammation is&#xD;
      discussed. The present study aims to evaluate the following effects in patients with IBS:&#xD;
&#xD;
        -  Primary endpoint: effect on the symptoms of IBS.&#xD;
&#xD;
        -  Secondary endpoint: intestinal wall permeability, integrity of the tight junctions as&#xD;
           measured by the change in zonulin concentration in the stool.&#xD;
&#xD;
        -  Further endpoints:&#xD;
&#xD;
             -  Inflammation parameters and anti-inflammatory laboratory parameters.&#xD;
&#xD;
             -  Biodiversity of the gastrointestinal microbiome.&#xD;
&#xD;
             -  histamine-associated parameters.&#xD;
&#xD;
             -  Constipation as a possible side effect.&#xD;
&#xD;
      For this purpose, a double-blind randomized controlled trial (RCT) is realized prospectively&#xD;
      in a monocentric outpatient-controlled study. The subjects take the test compound daily&#xD;
      (verum, reference substance) for 12 weeks and document the intake of the study-substance,&#xD;
      intake of medications, stool-frequency and consistency. They receive &quot;before&quot; and &quot;after&quot; the&#xD;
      intervention phase a blood and stool analysis for the determination of parameters for&#xD;
      intestinal wall integrity (zonulin) inflammation (hsCRP, interleukin-10, calprotectin),&#xD;
      histamine metabolism, microbiome diversity. The pilot study is realized ahead of the detailed&#xD;
      planning of a later main study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2018</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Abdominal discomfort or pain</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom improvement with defaecation</measure>
    <time_frame>3 months</time_frame>
    <description>0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stool frequency associated with abdominal discomfort or pain (more or less frequent)</measure>
    <time_frame>3 months</time_frame>
    <description>0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stool consistency associated with abdominal discomfort or pain (softer or harder)</measure>
    <time_frame>3 months</time_frame>
    <description>0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stool laboratory parameter: Firmicutes</measure>
    <time_frame>3 months</time_frame>
    <description>Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Firmicutes (CFU/g stool)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool laboratory parameter: Bacteroidetes</measure>
    <time_frame>3 months</time_frame>
    <description>Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Bacteroidetes (CFU/g stool)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool laboratory parameter: Ratio: Bacteroidetes/Firmicutes</measure>
    <time_frame>3 months</time_frame>
    <description>Genotyping of bacteria in stool, before and after intake of study substance; Computation of Ratio: Bacteroidetes/Firmicutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool laboratory parameter: Butyrat Producers</measure>
    <time_frame>3 months</time_frame>
    <description>Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Butyratproducing bacteria (CFU/g stool)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool laboratory parameter: Clostridia</measure>
    <time_frame>3 months</time_frame>
    <description>Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Clostridia (CFU/g stool)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool laboratory parameter: Histaminproducers,</measure>
    <time_frame>3 months</time_frame>
    <description>Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Histaminproducing bacteria (CFU/g stool)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool laboratory parameter: H2S producers</measure>
    <time_frame>3 months</time_frame>
    <description>Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of H2S-producing bacteria (CFU/g stool)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change of permeability (Leaky-Gut)</measure>
    <time_frame>3 months</time_frame>
    <description>Zonulin (&lt; 55 ng/ml) in stool</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of bowel inflammation</measure>
    <time_frame>3 months</time_frame>
    <description>Calprotectin (&lt; 50 mg/l) in stool</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of permeability of mucosa</measure>
    <time_frame>3 months</time_frame>
    <description>Alpha 1-Antitrypsin (&lt; 27,5 mg/dl) in stool</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of the inflammation mediator</measure>
    <time_frame>3 months</time_frame>
    <description>Histamin (&lt; 600 ng/ml) in stool</description>
  </other_outcome>
  <other_outcome>
    <measure>Efficacy of binding and elimination of ammoniak</measure>
    <time_frame>3 months</time_frame>
    <description>Ammoniak (11-51 µmol/l) in blood / serum</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of inflammation</measure>
    <time_frame>3 months</time_frame>
    <description>high sensitivity C-reactive protein (mg/l) in blood / serum</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of anti-inflammatory mediator</measure>
    <time_frame>3 months</time_frame>
    <description>Interleukin-10 (&lt; 9,1 pg/ml) in blood / serum</description>
  </other_outcome>
  <other_outcome>
    <measure>Possible release of metal ions</measure>
    <time_frame>3 months</time_frame>
    <description>Aluminium (&lt; 11 µg/l) in blood / serum</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of histamin metabolism</measure>
    <time_frame>3 months</time_frame>
    <description>Di-Amino-Oxydase (&gt; 10 U/ml) in blood / serum</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <condition>Microbial Colonization</condition>
  <condition>Intestinal Disease</condition>
  <arm_group>
    <arm_group_label>Panaceo MED</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Zeolite, Medicinal product, class IIa for oral intake, daily intake of 2 sachets (3 g), for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Micro crystalline cellulose daily intake of 2 sachets (3 g), for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Zeolite</intervention_name>
    <description>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.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Panaceo MED</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Frequency of discomfort or pain in the abdomen in the last 3 months, more than 1 day&#xD;
             per week.&#xD;
&#xD;
          -  Start of the discomfort or pain more than 6 months ago.&#xD;
&#xD;
          -  Improvement of the discomfort or pain associated with bowel movements sometimes,&#xD;
             often, frequently, always.&#xD;
&#xD;
          -  Association of the discomfort or pain with a frequency change in bowel movements&#xD;
             sometimes, often, frequently, always.&#xD;
&#xD;
          -  Association of the discomfort or pain with a change in stool-consistency sometimes,&#xD;
             often, frequently, always.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age: younger than 18, older than 80.&#xD;
&#xD;
          -  Diagnosed inflammatory bowel disease (M. Crohn, Colitis Ulcerosa)&#xD;
&#xD;
          -  Diagnosed nutritional idiosyncrasy&#xD;
&#xD;
          -  Cancer treatment in the last 12 weeks&#xD;
&#xD;
          -  Depression in the last 12 weeks&#xD;
&#xD;
          -  Intake of weight loss supporting medication (Lipase inhibitors)&#xD;
&#xD;
          -  Alcohol, nicotine, drug-abuse&#xD;
&#xD;
          -  Status after organ-transplantation, intake of immunosuppressants&#xD;
&#xD;
          -  Acute or chronic neurologic or psychiatric disease&#xD;
&#xD;
          -  Acute or chronic heart disease or kidney disease&#xD;
&#xD;
          -  Acute or chronic liver damage or any other organ damages&#xD;
&#xD;
          -  Transient severe obstipation in the last 4 weeks&#xD;
&#xD;
          -  Transient acute diarrhea in the last 4 weeks (e.g. intestinal infection)&#xD;
&#xD;
          -  Intestinal cancer&#xD;
&#xD;
          -  Intake of Panaceo MED or other Zeolite in the last 4 weeks&#xD;
&#xD;
          -  Type I Diabetes or severe metabolic disease&#xD;
&#xD;
          -  Infection with fever in the last 4 weeks&#xD;
&#xD;
          -  Intake of cortisone or antibiotics in the last 4 weeks&#xD;
&#xD;
          -  Planed journey of more than 14 days in the next 12 weeks (change of nutritional&#xD;
             habits)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ventzislav Petkov, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physician</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SCIgenia GmbH</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>26500463</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>March 23, 2021</last_update_submitted>
  <last_update_submitted_qc>March 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Zeolite</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03817645
org study id: PCeo-17
nct id: NCT03817645
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Abdominal discomfort or pain
time frame: 3 months
description: 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.
measure: Symptom improvement with defaecation
time frame: 3 months
description: 0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.
measure: Stool frequency associated with abdominal discomfort or pain (more or less frequent)
time frame: 3 months
description: 0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.
measure: Stool consistency associated with abdominal discomfort or pain (softer or harder)
time frame: 3 months
description: 0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.
measure: Stool laboratory parameter: Firmicutes
time frame: 3 months
description: Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Firmicutes (CFU/g stool)
measure: Stool laboratory parameter: Bacteroidetes
time frame: 3 months
description: Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Bacteroidetes (CFU/g stool)
measure: Stool laboratory parameter: Ratio: Bacteroidetes/Firmicutes
time frame: 3 months
description: Genotyping of bacteria in stool, before and after intake of study substance; Computation of Ratio: Bacteroidetes/Firmicutes
measure: Stool laboratory parameter: Butyrat Producers
time frame: 3 months
description: Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Butyratproducing bacteria (CFU/g stool)
measure: Stool laboratory parameter: Clostridia
time frame: 3 months
description: Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Clostridia (CFU/g stool)
measure: Stool laboratory parameter: Histaminproducers,
time frame: 3 months
description: Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Histaminproducing bacteria (CFU/g stool)
measure: Stool laboratory parameter: H2S producers
time frame: 3 months
description: Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of H2S-producing bacteria (CFU/g stool)
measure: Change of permeability (Leaky-Gut)
time frame: 3 months
description: Zonulin (< 55 ng/ml) in stool
measure: Change of bowel inflammation
time frame: 3 months
description: Calprotectin (< 50 mg/l) in stool
measure: Change of permeability of mucosa
time frame: 3 months
description: Alpha 1-Antitrypsin (< 27,5 mg/dl) in stool
measure: Change of the inflammation mediator
time frame: 3 months
description: Histamin (< 600 ng/ml) in stool
measure: Efficacy of binding and elimination of ammoniak
time frame: 3 months
description: Ammoniak (11-51 µmol/l) in blood / serum
measure: Change of inflammation
time frame: 3 months
description: high sensitivity C-reactive protein (mg/l) in blood / serum
measure: Change of anti-inflammatory mediator
time frame: 3 months
description: Interleukin-10 (< 9,1 pg/ml) in blood / serum
measure: Possible release of metal ions
time frame: 3 months
description: Aluminium (< 11 µg/l) in blood / serum
measure: Change of histamin metabolism
time frame: 3 months
description: Di-Amino-Oxydase (> 10 U/ml) in blood / serum
arm group label: Panaceo MED
arm group type: Experimental
description: Zeolite, Medicinal product, class IIa for oral intake, daily intake of 2 sachets (3 g), for 3 months.
arm group label: Control
arm group type: Placebo Comparator
description: Micro crystalline cellulose daily intake of 2 sachets (3 g), for 3 months.
intervention type: Other
intervention name: Zeolite
description: 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 group label: Control
arm group label: Panaceo MED
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ventzislav Petkov, M.D.
role: Principal Investigator
affiliation: Physician
facility: 
country: Austria
citation: 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.
PMID: 26500463
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Irritable Bowel Syndrome
mesh term: Intestinal Diseases
mesh term: Syndrome
sharing ipd: No