Irritable Bowel SyndromePCeo-17NCT03817645
Panaceo "MED" for IBS (Irritable Bowel Syndrome)
A study testing Zeolite in people with Irritable Bowel Syndrome and Microbial Colonization, run by Scigenia GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Microbial Colonization, Intestinal Disease
- What is being tested?
- Zeolite
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteAustria
- Study dates
- 9 Mar 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot-trial on the Use of the Panaceo Medicine Product "MED" for the Treatment of 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:
Read more
- 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.
- Being tested
- Zeolite
- Keywords
- Zeolite
- Medical subject headings
- Irritable Bowel Syndrome, Communicable Diseases, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZeoliteOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Panaceo MED | Experimental | Zeolite, Medicinal product, class IIa for oral intake, daily intake of 2 sachets (3 g), for 3 months. Receives: Other: Zeolite |
| Control | Placebo comparator | Micro crystalline cellulose daily intake of 2 sachets (3 g), for 3 months. Receives: Other: Zeolite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Symptom improvement with defaecation
0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (7)
Stool laboratory parameter: Firmicutes
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Firmicutes (CFU/g stool)
Measured: 3 months
Stool laboratory parameter: Bacteroidetes
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Bacteroidetes (CFU/g stool)
Measured: 3 months
Stool laboratory parameter: Ratio: Bacteroidetes/Firmicutes
Genotyping of bacteria in stool, before and after intake of study substance; Computation of Ratio: Bacteroidetes/Firmicutes
Measured: 3 months
Stool laboratory parameter: Butyrat Producers
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Butyratproducing bacteria (CFU/g stool)
Measured: 3 months
Stool laboratory parameter: Clostridia
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Clostridia (CFU/g stool)
Measured: 3 months
Stool laboratory parameter: Histaminproducers,
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Histaminproducing bacteria (CFU/g stool)
Measured: 3 months
Stool laboratory parameter: H2S producers
Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of H2S-producing bacteria (CFU/g stool)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start9 Mar 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scigenia GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ventzislav Petkov, M.D., Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817645
- Sponsor's protocol ID
- PCeo-17
- Acronym
- PCeo-17
- Status last verified
- Mar 2021
- First submitted
- 19 Dec 2018
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26500463
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-trial on the Use of the Panaceo Medicine Product "MED" for the Treatment of IBS (Irritable Bowel Syndrome)
- ClinicalTrials.gov ID
- NCT03817645
- Acronym / sponsor ID
- PCeo-17 / PCeo-17
- Keywords
- Zeolite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Scigenia GmbHUniversity, hospital or other
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panaceo MED | Experimental | Other: ZeoliteZeolite, Medicinal product, class IIa for oral intake, daily intake of 2 sachets (3 g), for 3 months. |
| Control | Placebo comparator | Other: ZeoliteMicro crystalline cellulose daily intake of 2 sachets (3 g), for 3 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZeoliteThe 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. | Other | Control, Panaceo MED |
Primary outcome
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.
Symptom improvement with defaecation
Time frame: 3 months
0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.
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.
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.
7 secondary outcomes
Stool laboratory parameter: Firmicutes
Time frame: 3 months
Stool laboratory parameter: Bacteroidetes
Time frame: 3 months
Stool laboratory parameter: Ratio: Bacteroidetes/Firmicutes
Time frame: 3 months
Stool laboratory parameter: Butyrat Producers
Time frame: 3 months
Stool laboratory parameter: Clostridia
Time frame: 3 months
Stool laboratory parameter: Histaminproducers,
Time frame: 3 months
Stool laboratory parameter: H2S producers
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Background: PubMed 26500463Lamprecht 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ventzislav Petkov, M.D. principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zeolite in people with Irritable Bowel Syndrome and Microbial Colonization, run by Scigenia GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal discomfort or pain (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03817645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.