Observational Study Evaluating the Number of Symptomatic Cystitis-like Episodes and Urinary Comfort of Women Consuming Cranberry, Cinnamon and Probiotic Strain Extracts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Occurence of symptomatic cystitis-like episodes
研究概览
简要总结
Cranberries are traditionally used for urinary comfort and prevention of urinary disorders of bacterial origin and despite an EFSA opinion invalidating the clinical efficacy of cranberries, its mechanism of action has been several times proposed by the scientific community: it would act by inhibiting the synthesis of P-fimbriae leading to a complete disappearance of these adhesins, and to bacterial-type deformation by lengthening of the cell body. Cinnamon and microbiotic strains could enhance this synergy.
This study aims to evaluate the effectiveness of a food supplement based on cranberry, cinnamon and microbiotic strains (Feminabiane CBU) on the symptoms of cystitis, urinary discomfort and the number of cystitis reported by women.
详细描述
Women who use or not the cranberry, cinnamon, and microbiotic blend are encouraged to complete a 6-month diary in which they report any urinary tract disorders they encounter.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having at least 2 symptomatic episodes of cystitis during the last 6 months including at least 1 episode confirmed as being bacterial cystitis (by an urine bacterial analysis or validated by a doctor (date of appointment, list of prescribed treatments) ;
- •Whose symptomatic episodes of cystitis over the past 6 months have had a significant impact on quality of life / urinary comfort (ACSS QoL> 2);
- •Having a smartphone compatible with the NURSTRIAL® data collection application;
- •Not opposing the collection and processing of their personal data.
排除标准
- •Presenting urinary discomfort with a severe impact on quality of life (ACSS QoL> 7) during the last 24 hours prior to inclusion;
- •Pregnant, breastfeeding or planning to become pregnant during the study;
- •Under antibiotic treatment (or during the last month preceding inclusion);
- •Under food supplementation with prebiotics or probiotics or having stopped it less than a month before inclusion;
- •Having had recourse to a prophylactic treatment (cranberry juice) 15 days before inclusion;
- •Having had local estrogen therapy during the 3 months preceding inclusion;
- •Diabetic;
- •Presenting an immunosuppressive disease;
- •Presenting pelvic floor abnormalities (Cystocele surgery, etc.);
- •Presenting or having a history of kidney disease (including kidney stones, urinary tract abnormalities, pyelonephritis, kidney failure, kidney transplantation);
- •For women consuming supplementation: known allergy to plants of the cranberry family or to one of the components of the products.
结局指标
主要结局
Occurence of symptomatic cystitis-like episodes
时间窗: At week 24
Number of symptomatic cystitis-like episodes reported by the subject self-assessed using the "typical" domain of the Acute Cystitis Symptom Score (ACCS) and defined by a score ranged between 6 to 18.
次要结局
- Mean time to onset of symptomatic episodes of the cystitis(At week 24)
- Effect of blend consumption in preventing symptomatic episode of cystitis(At week 24)
- Change of the quality of life related to urinary discomfort(At weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24)
- Severity of urinary discomfort(Every day during each urinary symptoms (Week 0 to Week 24))
- Time-period without antibiotics(At week 24)