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

Scigenia

Status

Completed

Conditions

Intestinal Disease

Irritable Bowel Syndrome

Microbial Colonization

Treatments

Other: Zeolite

Study type

Interventional

Funder types

Other

Identifiers

NCT03817645

PCeo-17

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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)