Irritable Bowel Syndrome Clinical Trial
— PCeo-17Official title:
Pilot-trial on the Use of the Panaceo Medicine Product "MED" for the Treatment of IBS (Irritable Bowel Syndrome)
NCT number | NCT03817645 |
Other study ID # | PCeo-17 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 9, 2018 |
Est. completion date | June 30, 2020 |
Verified date | March 2021 |
Source | Scigenia GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Austria | SCIgenia GmbH | Vienna |
Lead Sponsor | Collaborator |
---|---|
Scigenia GmbH |
Austria,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change of permeability (Leaky-Gut) | Zonulin (< 55 ng/ml) in stool | 3 months | |
Other | Change of bowel inflammation | Calprotectin (< 50 mg/l) in stool | 3 months | |
Other | Change of permeability of mucosa | Alpha 1-Antitrypsin (< 27,5 mg/dl) in stool | 3 months | |
Other | Change of the inflammation mediator | Histamin (< 600 ng/ml) in stool | 3 months | |
Other | Efficacy of binding and elimination of ammoniak | Ammoniak (11-51 µmol/l) in blood / serum | 3 months | |
Other | Change of inflammation | high sensitivity C-reactive protein (mg/l) in blood / serum | 3 months | |
Other | Change of anti-inflammatory mediator | Interleukin-10 (< 9,1 pg/ml) in blood / serum | 3 months | |
Other | Possible release of metal ions | Aluminium (< 11 µg/l) in blood / serum | 3 months | |
Other | Change of histamin metabolism | Di-Amino-Oxydase (> 10 U/ml) in blood / serum | 3 months | |
Primary | 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 | |
Primary | Symptom improvement with defaecation | 0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always. | 3 months | |
Primary | 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 | |
Primary | 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 | Stool laboratory parameter: Firmicutes | Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Firmicutes (CFU/g stool) | 3 months | |
Secondary | Stool laboratory parameter: Bacteroidetes | Genotyping of bacteria in stool, before and after intake of study substance; Prevalence Bacteroidetes (CFU/g stool) | 3 months | |
Secondary | Stool laboratory parameter: Ratio: Bacteroidetes/Firmicutes | Genotyping of bacteria in stool, before and after intake of study substance; Computation of Ratio: Bacteroidetes/Firmicutes | 3 months | |
Secondary | Stool laboratory parameter: Butyrat Producers | Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Butyratproducing bacteria (CFU/g stool) | 3 months | |
Secondary | Stool laboratory parameter: Clostridia | Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Clostridia (CFU/g stool) | 3 months | |
Secondary | Stool laboratory parameter: Histaminproducers, | Genotyping of bacteria in stool, before and after intake of study substance; Prevalence of Histaminproducing bacteria (CFU/g stool) | 3 months | |
Secondary | 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) | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03720314 -
Microbiota Profiling in IBS
|
||
Recruiting |
NCT06166563 -
Exercise, Irritable Bowel Syndrome and Fibromyalgia
|
N/A | |
Completed |
NCT05213910 -
Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains
|
N/A | |
Recruiting |
NCT05985018 -
Traditional Dietary Advice Vs. Mediterranean Diet in IBS
|
N/A | |
Completed |
NCT04486469 -
Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study.
|
N/A | |
Completed |
NCT06407609 -
Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS
|
N/A | |
Completed |
NCT04656730 -
Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas
|
Phase 4 | |
Completed |
NCT04145856 -
Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico
|
Phase 4 | |
Recruiting |
NCT04138225 -
The Ecological Role of Yeasts in the Human Gut
|
||
Active, not recruiting |
NCT03586622 -
One Year Home Monitoring and Treatment of IBS Patients
|
N/A | |
Completed |
NCT05207618 -
Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant
|
N/A | |
Not yet recruiting |
NCT06369753 -
Visible Abdominal Distension
|
N/A | |
Not yet recruiting |
NCT05157867 -
In Vivo Effects of Amylase Trypsin Inhibitors
|
N/A | |
Not yet recruiting |
NCT05100719 -
The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)
|
N/A | |
Recruiting |
NCT05001997 -
Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome
|
N/A | |
Recruiting |
NCT02953171 -
Probiotics in the Treatment of Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT03266068 -
Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
|
||
Completed |
NCT02977975 -
Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
|
N/A | |
Completed |
NCT03318614 -
Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster
|
Phase 2/Phase 3 | |
Completed |
NCT02980406 -
The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level
|
N/A |