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Completed

NCT Number: NCT03817645

Panaceo "MED" for 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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Communicable Diseases Digestive System Diseases Disease Attributes Gastrointestinal Diseases Infections Intestinal Disease Intestinal Diseases Microbial Colonization Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SCIgenia GmbH

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Zeolite

Other

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Scigenia GmbH

Other

Registry information

Official study title

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

Acronym: PCeo-17

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 25, 2019
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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