NCT03449628已完成不适用
L. Casei DG® (Lactobacillus Paracasei CNCMI1572) in the Treatment of Patients With Irritable Bowel Syndrome: a Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study.
SOFAR S.p.A.23 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2017年11月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 23
- 主要终点
- Proportion of patients who have a response in pain
研究概览
简要总结
To assess the effect of L. casei DG® (Lactobacillus paracasei CNCMI1572; Enterolactis® plus) on abdominal symptoms and gut microbiota metabolism/composition in non constipated patients with IBS (Irritable Bowel Syndrome). Patients will be randomized to receive L. casei DG® capsules, b.i.d. for 12 weeks the a 4 weeks Follow Up period will follow.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age > 18 years and ≤ 65 years
- •A positive diagnosis of non constipated IBS (i.e., IBS-D and IBS-M, both males and females), according to Rome IV criteria.
- •A negative outcome of colonoscopy performed within 5 years before screening if patient is at least 50 years old, or if patient meet any of the following alarm features:
- •Has a documented weight loss within the past 6 months; or
- •Has nocturnal symptoms; or
- •Has a familiar history of colon cancer; or
- •Has blood mixed with their stool (excluding blood from hemorroids).
- •Negative relevant additional screening or consultation whenever appropriate
- •Ability to conform to the study protocol.
排除标准
- •Patients with IBS-C or IBS-U according to Rome IV criteria
- •Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values, (i.e..liver or kidney functional levels 2-times greater than the upper reference values)
- •Ascertained intestinal organic diseases, including celiac disease, food allergies or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
- •Previous major abdominal surgery.
- •Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable).
- •Untreated food intolerance such as ascertained or suspected lactose intolerance, as defined by anamnestic evaluation or, if appropriate, lactose breath test.
- •Use of probiotics or topical and/or systemic antibiotic therapy during the last month.
- •Systematic/frequent use of contact laxatives.
- •Pregnant females or females of childbearing potential in the absence of effective contraceptive methods.
- •Inability to conform to protocol.
- •Treatment with any investigational drug within the previous 30 days.
- •Recent history or suspicion of alcohol abuse or drug addiction.
- •Presence of red or white flags at the Rome IV Psychosocial Alarm Questionnaire for Functional gastrointestinal Disorders.
结局指标
主要结局
Proportion of patients who have a response in pain
时间窗: 12 weeks
Patients who record on ≥ 50% of the days a reduction of ≥ 30% from their average baseline score for their worst abdominal pain.The standard 11-point numeric rating scale (from 0=none to 10=worst possible pain) will be used to measure abdominal pain.
Proportion of patients who have a response in stool consistencies
时间窗: 12 weeks
Patients who record a stool-consistency score \< 5 in the same days in which they record a reduction of ≥ 30% from their average baseline score for their worst abdominal pain .For abnormal defecation, stool frequency and form will be measured using the Bristol Stool Form Scale (BSFS).
次要结局
- Evaluation of Pain relief(16 weeks)
- Evaluation of global symptom score(16 weeks)
- Relief of IBS symptoms(16 weeks)
- IBS-SSS score questionnaire (Severity Scoring System )(16 weeks)
- Improvement in stool consistency(16 weeks)
- Satisfaction with treatment(16 weeks)
- Quality of life(16 weeks)
- Intake of rescue medication(16 weeks)
- gut microbiota composition(16 weeks)
- Short Chain Fatty Acids (SCFA)(16 weeks)
- Free Aminoacids(16 weeks)
- Biogenic Amines(16 weeks)
- Gut permeability for zonulin(16 weeks)
- Gut permeability for citrulline(16 weeks)
- Gut permeability for PV-1 (Plasmalemma vesicle-associated) protein(16 weeks)
- L. casei DG® strain in the feces(16 weeks)
研究者
研究点 (23)
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