Pilot-trial on the Use of the Panaceo Medicine Product "MED" for the Treatment of IBS (Irritable Bowel Syndrome)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Abdominal discomfort or pain
研究概览
简要总结
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:
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Primary endpoint: effect on the symptoms of IBS.
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Secondary endpoint: intestinal wall permeability, integrity of the tight junctions as measured by the change in zonulin concentration in the stool.
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Further endpoints:
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Inflammation parameters and anti-inflammatory laboratory parameters.
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Biodiversity of the gastrointestinal microbiome.
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histamine-associated parameters.
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Age: younger than 18, older than
- •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)
结局指标
主要结局
Abdominal discomfort or pain
时间窗: 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.
Stool consistency associated with abdominal discomfort or pain (softer or harder)
时间窗: 3 months
0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.
Symptom improvement with defaecation
时间窗: 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)
时间窗: 3 months
0 - never or rarely, 1 - sometimes, 2 - often, 3 - frequently, 4 - always.
次要结局
- Stool laboratory parameter: Butyrat Producers(3 months)
- Stool laboratory parameter: Bacteroidetes(3 months)
- Stool laboratory parameter: Ratio: Bacteroidetes/Firmicutes(3 months)
- Stool laboratory parameter: Clostridia(3 months)
- Stool laboratory parameter: H2S producers(3 months)
- Stool laboratory parameter: Firmicutes(3 months)
- Stool laboratory parameter: Histaminproducers,(3 months)