A Randomized, Cross-over, Placebo-Controlled, Double-Blind Clinical Trial on the Efficacy and Safety of Oral Administration of Postibiotic by FOS Fermentation From Lactobacillus Paracasei in the Treatment of Irritable Bowel Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Reduction in symptom intensity
研究概览
简要总结
Irritable bowel syndrome (IBS) is a highly prevalent functional pathology which currently has no real standardized and effective therapy, despite having a significant impact on quality of life and on social-health costs.
Post-biotics have demonstrated in various in vitro and in vivo studies the ability to modulate the microbiota, the intestinal barrier function, the immune response as well as having systemic effects, with prospects for good efficacy in treatment of IBS.
详细描述
PostbiotiX Slowing is a food supplement based on Fermented FOS from Lactobacillus paracasei CNCM I-5220, mallow and chamomile.
The Fermented FOS from Lactobacillus paracasei CNCM I-5220 (postbiotic) is the result of a controlled fermentation. The fermentation process allows to eliminate all the individual variability that depends on the microbiota, the diet and the psycho-physical conditions of the single individual, offering a mixture of bacterial metabolites and fermented fiber (postbiotic), which has the functional activity. In addition, as FOS is already fermented it does not induce the formation of gas typical of fiber fermentation in IBS patients, thus providing all the beneficial effects of the fiber without its side effects.
The fermented FOS from Lactobacillus paracasei CNCM I-5220 (postbiotic) is easily absorbed by the gut.
Dosage and method of use: PostbiotiX Slowing 4 g sachets, administered at the dosage of one sachet a day. To pour the contents of the sachet in a glass, add 150 ml of water, mix until complete dissolution of the powder and taken immediately, preferably as soon as awakened, and away from meals.
Ingredients: Maltodextrin, Aroma, Fermented FOS from Lactobacillus paracasei CNCM I-5220, mallow (Malva sylvestris L.) flowers and leaves d.e. tit. 20% polysaccharides, chamomile (Matricaria chamomilla L.) flowers d.e. tit. 0.3% apigenin, acidity regulator: citric acid; anti-caking agent: silicon dioxide; sweetener: sucralose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years
- •IBS diagnosis according to ROME IV criteria
- •Mild-moderate disease defined by IBS-SSS questionnaire at the baseline visit and after the washout period
- •Signed Informed Consent
- •Patients' ability to comply with the study procedures
- •Stable diet within two months prior to the screening visit
- •Negative colonoscopy (only > 50 years old patients)
排除标准
- •Therapy with drugs or supplements included in the prohibited list
- •Malignancy or history of malignancy, except patients with a history of surgically removed extraintestinal malignancy and a 5-year disease-free interval
- •Unstable psychiatric pathology
- •Organic bowel disease
- •Major abdominal surgery, except appendectomy and cholecystectomy
- •Relevant organic, systemic, metabolic pathologies or significant laboratory test abnormalities
- •Pregnant or nursing women
- •Patients with known hypersensitivity to one or more components of the product
结局指标
主要结局
Reduction in symptom intensity
时间窗: 10 weeks
Evaluated using a symptom measurement scale, at each visit, on a 4-point Likert scale (IBS symptom scale; 4 symptoms for a minimum sum score of 0, maximum 12).
次要结局
- Change from baseline after treatment in QqL:(up to 10 days)
- Fecal metagenomics:(up to 10 days)
- Change from baseline in IBS-SSS (symptom severity score)(up to 4 weeks)
- Change from baseline after treatment in NRS:(up to 10 days)
- Change from baseline after treatment in HADS:(up to 10 days)
- Analyses of metabolomic:(up to 10 days)
- Adequate overall symptom relief after treatment,(up to 10 days)