Panaceo "MED" for IBS (Irritable Bowel Syndrome)

NCT03817645 | Completed

• 1 other identifier: PCeo-17
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Microbial Colonization; Intestinal Disease

Keywords

Zeolite

Outcome Measures

Primary Outcomes (4)

• Abdominal discomfort or pain

  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.

  3 months

• Symptom improvement with defaecation

  0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.

  3 months

• Stool frequency associated with abdominal discomfort or pain (more or less frequent)

  0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.

  3 months

• Stool consistency associated with abdominal discomfort or pain (softer or harder)

  0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.

  3 months

Secondary Outcomes (7)

• Stool laboratory parameter: Firmicutes

  3 months

• Stool laboratory parameter: Bacteroidetes

  3 months

• Stool laboratory parameter: Ratio: Bacteroidetes/Firmicutes

  3 months

• Stool laboratory parameter: Butyrat Producers

  3 months

• Stool laboratory parameter: Clostridia

  3 months

Other Outcomes (9)

• Change of permeability (Leaky-Gut)

  3 months

• Change of bowel inflammation

  3 months

• Change of permeability of mucosa

  3 months

Study Arms (2)

Panaceo MED

EXPERIMENTAL

Zeolite, Medicinal product, class IIa for oral intake, daily intake of 2 sachets (3 g), for 3 months.

Other: Zeolite

Control

PLACEBO COMPARATOR

Micro crystalline cellulose daily intake of 2 sachets (3 g), for 3 months.

Other: Zeolite

Interventions

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.

Control; Panaceo MED

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Scigenia GmbH: lead

Study Sites (1)

SCIgenia GmbH

Vienna, 1090, Austria

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome; Communicable Diseases; Intestinal Diseases

Interventions

Zeolites

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Gastrointestinal Diseases; Digestive System Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aluminum Silicates; Aluminum Oxide; Aluminum Compounds; Inorganic Chemicals; Silicates; Minerals; Oxides; Oxygen Compounds; Silicic Acid; Silicon Dioxide; Silicon Compounds

Study Officials

• Ventzislav Petkov, M.D.

  Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 25, 2019
• Study Start: March 9, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2020
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)