Clinical trial NCT03817645: Panaceo "MED" for IBS (Irritable Bowel Syndrome)
Official title: Pilot-trial on the Use of the Panaceo Medicine Product "MED" for the Treatment of IBS (Irritable Bowel Syndrome)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Microbial Colonization
Intestinal Disease
Keywords: Zeolite
Lead sponsor: Scigenia GmbH
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Abdominal discomfort or pain
timeFrame: 3 months
measure: Symptom improvement with defaecation
timeFrame: 3 months
measure: Stool frequency associated with abdominal discomfort or pain (more or less frequent)
timeFrame: 3 months
measure: Stool consistency associated with abdominal discomfort or pain (softer or harder)
timeFrame: 3 months
Secondary outcomes:
measure: Stool laboratory parameter: Firmicutes
timeFrame: 3 months
measure: Stool laboratory parameter: Bacteroidetes
timeFrame: 3 months
measure: Stool laboratory parameter: Ratio: Bacteroidetes/Firmicutes
timeFrame: 3 months
measure: Stool laboratory parameter: Butyrat Producers
timeFrame: 3 months
measure: Stool laboratory parameter: Clostridia
timeFrame: 3 months
measure: Stool laboratory parameter: Histaminproducers,
timeFrame: 3 months
measure: Stool laboratory parameter: H2S producers
timeFrame: 3 months
Other outcomes:
measure: Change of permeability (Leaky-Gut)
timeFrame: 3 months
measure: Change of bowel inflammation
timeFrame: 3 months
measure: Change of permeability of mucosa
timeFrame: 3 months
measure: Change of the inflammation mediator
timeFrame: 3 months
measure: Efficacy of binding and elimination of ammoniak
timeFrame: 3 months
measure: Change of inflammation
timeFrame: 3 months
measure: Change of anti-inflammatory mediator
timeFrame: 3 months
measure: Possible release of metal ions
timeFrame: 3 months
measure: Change of histamin metabolism
timeFrame: 3 months
Locations:
city: Vienna
country: Austria
facility: SCIgenia GmbH
Study officials:
affiliation: Physician
name: Ventzislav Petkov, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.