Effect of a Mixture of Probiotics (Lactibiane Reference) in Patients With Irritable Bowel Syndrome Predominantly Constipation and Assessment of a Potential Biomarker (Resolvin D1): an Exploratory Study
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
- Change of the severity of IBS-C symptoms
研究概览
简要总结
Probiotics efficacy is mainly assessed by subjective endpoints such as the FDA responder rate or global relief, which partly explain contradictory results obtained in clinical trials with probiotic bacteria. Objective biomarkers of IBS will allow to measure the efficacy of probiotics. In the case of IBS-C, serum resolvin-D1 appears to be an interesting candidate due to its non-invasive and discriminating character compared to a healthy population. It is, inversely correlated with the severity of symptoms. Resolvin-D1 modulates the duration and intensity of inflammation by regulating the transcription of cytokines, chemokines and their receptors as well as other proteins involved in inflammation. Resolvin D1 could serve as a predictor of probiotic response based on its baseline value.
详细描述
Resolvin D1 levels will be measured in patients with IBS-C as defined by the Rome IV criteria before 6 and 12 weeks after supplementation with a mixture of probiotics. The progression of IBS-C symptoms will also be assessed throughout the study.
The correlation with resolvin D1 levels and the severity of IBS symptoms will be investigated. The efficacy of the probiotic mixture in relieving the symptoms of IBS-C will be measured and compared based on the levels of resolvin D1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Irritable Bowel Syndrome with constipation (IBS-C) according to Rome IV criteria ;
- •IBS-SSS between 175-300 in the last 10 days ;
- •Have experienced abdominal pain ≥ 40 according to the IBS-SSS questionnaire (abdominal pain item) during the last 10 days ;
- •Whose abdominal pain / discomfort has had a significant impact on daily life during the past 10 days (impact ≥2 on a 5-point likert scale (from 0: no impact to 5: extreme impact) ;
- •Ability to understand instructions and complete questionnaires Nurstrial APP.
- •Affiliate or beneficiary of a social security ;
- •Having given their free, informed and written consent.
排除标准
- •CPRu > 10 mg/l
- •Pregnant or breastfeeding woman, woman planning a pregnancy during the study period ;
- •Intolerance or proven food allergy ;
- •BMI <18.5 kg / m2 or BMI> 35 kg / m2 ;
- •Diagnosis or known history of IBS-D, IBS-M, or unclassified forms of IBS, or other gastrointestinal pathologies ;
- •With current first-line IBS-C treatment or second-line treatment ;
- •alternative non pharmacological treatment ;
- •Drug treatment affecting visceral sensitivity or intestinal transit ;
- •dietary modification (exclusion of FODMAPs, prebiotic) or lifestyle ;
- •Excessive smoking or drinking ;
- •Having or planning bariatric surgery,
- •With known pathologies affecting gut function ;
- •With a deviant eating behavior,
- •Treated with antibiotics in the 3 months preceding inclusion,
- •Under legal protection,
- •Already included in a clinical trial,
- •With severely impaired physical/psychological health may affect study participation.
研究组 & 干预措施
Probiotics mixture
Daily supplementation with a mixture of probiotics for 12 weeks
干预措施: Probiotics mixture (Dietary Supplement)
结局指标
主要结局
Change of the severity of IBS-C symptoms
时间窗: At weeks 0, 4, 8 and 12
Measured by the composite IBS-SSS (Irritable Bowel Syndrome-Severity Scale Scoring) system, compared to the baseline IBS-SSS value. Minimum : 0 (best condition) to maximum (worse condition): 500
次要结局
- Change of the stool frequency(At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12)
- Assessing the satisfaction regarding the mixture of probiotics(At weeks 4, 8 and 12)
- Assessing the relationship between baseline resolvin D1 levels and response to the probiotics supplementation measured by the responders rate (outcome 17)(At week 12)
- Global assessment of symptoms relief(At weeks 4, 8 and 12)
- Change of the number of days with abdominal pain(At weeks 4, 8 and 12)
- Change of the IBS-related quality of life(At weeks 4, 8 and 12)
- Change of the severity of abdominal distension (bloating)(At weeks 4, 8 and 12)
- Assessing the tolerance of the probiotics mixture(At weeks 6 and 12)
- Change of the satisfaction with bowel habits(At weeks 4, 8 and 12)
- Change of Resolvin-D1 levels(At weeks 8 and 12)
- Change of CPRu (C Reactive Protein-ultrasensitive) levels(At weeks 8 and 12)
- Change of the intestinal microbiota(At weeks 6 and 12)
- Change of the stools consistency(At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12)
- Change of number of drugs consumption to alleviate the IBS-C symptoms(At weeks 4, 8 and 12)
- Change of the severity of addominal pain(At weeks 4, 8 and 12)
- Change of the Quality of Life(At weeks 4, 8 and 12)
- Assessing the responders rate(At weeks 4, 8 and 12)
- Assessing the relationship between baseline microbiota and response to the probiotics supplementation measured by the responders rate (outcome 17)(At week 12)
- Assessing the relationship between resolvin D1 levels and symptoms severity mesured by IBS-SSS symptoms scores(At week 12)
- Assessing the global improvement(At weeks 4, 8 and 12)