Effects of Vivatlac Synbiotic in Patients With Irritable Bowel Syndrome - A Randomized, Double-blind, Placebo-Controlled, 36 Weeks Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Severity of IBS using the IBS-Severity Scoring System (IBS-SSS)
研究概览
简要总结
Multi-center,randomized, double-blind, placebo-controlled, 36 weeks trial investigating the effects of a nine-strain synbiotic (Vivatlac Synbiotikum) in IBS patients
详细描述
The study design is a multi-centre, randomized, double-blind, placebo controlled clinical trial in patients diagnosed with IBS. Diagnosis of IBS with the World Gastroenterology Organisation's IBS questionnaire for health care providers. Assessment of severity of IBS by using the IBS Severity of Symptoms Scale (IBS-SSS). IBS patients with moderate to severe IBS will be included into the study (IBS-SSS ≥ 175). A four weeks screening phase is used to evaluate patients' IBS symptoms and stool characteristics using a patient diary.
The screening phase is followed by treatment with one capsule per day of a nine-strain synbiotic (Vivatlac® Synbiotikum) or with an identical looking placebo for thirty-six weeks.
Each capsule of Vivatlac® Synbiotikum contains a total of 4.5 x 10^9 colony forming units (CFU) of nine different probiotic bacteria. Probiotic bacteria strains and their CFU amount per capsule are: Lactococcus lactis Ll-23, 9.00 x 10^8 CFU; Lactobacillus helveticus SP 27, 9.00 x 10^8 CFU; Bifidobacterium longum Bl-05, 6.75 x 10^8 CFU; Bifidobacterium longum ES-1, 4.50 x 10^8 CFU; Lacticaseibacillus rhamnosus Lr-32, 4.50 x 10^8 CFU; Streptococcus thermophiles St-21, 4.50 x 10^8 CFU; Lacticaseibacillus casei Lc-11, 2.25 x 10^8 CFU; Lactiplantibacillus plantarum Lp-115, 2.25 x 10^8 CFU; Bifidobacterium bifidum Bb-02, 2.25 x 10^8 CFU. In addition, each capsule contains 68 mg of fructooligosaccharides (FOS).
Treatment effects will be assessed by using the IBS-Severity Scoring System (IBS-SSS), before the start of treatment and after 4, 8, 12, 24, and 36 weeks of treatment. Changes of IBS severity will be assessed by using the IBS-Global Improvement Scale (IBS-GIS), before the start of treatment and after 4, 8, 12, 24, and 36 weeks of treatment. Patients will be assessed for IBS relief by using the IBS-Adequate Relief scale (IBS-AR), before the start of treatment and after 4, 8, 12, 24, and 36 weeks of treatment. Stool form characteristics will be assessed with the Bristol Stool Form Scale, before the start of treatment and after 4, 8, 12, 24, and 36 weeks treatment. Quality of life (QoL) will be assessed before the start of treatment and after 12 and 36 weeks of treatment using the IBS-QoL questionnaire. Emotional suppression will be assessed before the start of treatment and after 12 and 36 weeks of treatment using the Courtauld Emotional Control Scale (CECS).
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, Care Provider, Investigator)
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
- •diagnosed for Irritable Bowel Syndrome using the IBS questionnaire for Health Care Providers of the World Global Gastroenterology Organization
- •IBS-SSS ≥ 175 points
排除标准
- •patients currently taking products containing probiotics or have taken this kind of products during the last 3 months
- •patients currently taking antibiotics or have taken antibiotics during the last 3 months
- •patients having a concurrent severe illness (malignancies, uncontrolled hypertension or diabetes, hepatic, renal or cardiac dysfunctions, serious neurological disorders, psychosis, respiratory disorders such as asthma or COPD, hyper- or hypothyroidism
- •patients having chronic bowel disorders other than IBS, including inflammatory bowel disease, gastroenteritis, stomach and duodenal cancer, celiac disease
- •patient being pregnant, lactating, or planning to become pregnant during the next 9 months
- •patient being diagnosed to have a lactose intolerance
- •patients using motility drugs or dietary fiber supplements withing 2 weeks before study start
- •patient taking anti-coagulant medication
- •patients have participated in another clinical trial within the last three months
研究组 & 干预措施
Placebo
Capsule containing maize starch with identical appearance as verum. One capsule taken per day before bedtime. Treatment duration 36 weeks.
干预措施: Placebo (Dietary Supplement)
Vivatlac Synbiotic
Vivatlac Synbiotic for 36 weeks. One capsule containing a mixture of nine different probiotic bacteria with a total amount of 4.5 x 10^9 colony forming units and 63 mg of fructooligosaccharides. One capsule taken per day before bedtime. Treatment duration 36 weeks.
干预措施: Vivatlac Synbiotic (Dietary Supplement)
结局指标
主要结局
Severity of IBS using the IBS-Severity Scoring System (IBS-SSS)
时间窗: Measured at enrollment into treatment phase, and after 12, and 36 weeks of treatment.
IBS-Severity Scoring System is a 5-question survey that asks: 1. the severity of abdominal pain, 2. frequency of abdominal pain, 3. severity of abdominal distention, 4.dissatisfaction with bowel habit, and 5. interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale. Each of the five question generates a maximum score of 100 point, and total scores can range from 0-500 with higher scores indicating severe symptoms. A decrease of 50 points is associated with a clinically meaningful improvement.
Changes of IBS severity using the IBS Global Improvement Scale (IBS-GIS)
时间窗: Measured after 12, and 36 weeks of treatment.
Patients answer the question "Have you felt any change in the severity of your symptoms over the past 7 days compared to how you felt before the medicine was given? The answers are recorded based on the 7-point scale: * I feel that the symptoms have worsened significantly * I feel that the symptoms have moderately worsened * I feel that the symptoms have slightly worsened * I feel no change * I feel a slight improvement * I feel moderate improvement * I feel significant improvement IBS-GIS score indicates: improvement if is \>4 or worsening if is\<4, no change if is 4
Changes in adequate relief of IBS-symptoms (IBS-AR)
时间窗: Measured after 12, and 36 weeks of treatment.
IBS-Adequate Relief (IBS-AR) is a dichotomous single item that asks participants "Over the past week (7 days) have you had adequate relief of your IBS symptoms? The answer is YES or NO.
次要结局
- Changes of stool form characteristics (Bristol Stool Form Scale)(Measured at enrollment into treatment phase, and after 4, 8, 12, 24 , and 36 weeks of treatment.)
- Changes of Emotional Suppression (Courtauld Emotional Control Scale, CECS)(Measured at enrollment into treatment phase, and after 12, and 36 weeks of treatment.)
- Changes of stool form characteristics (Bristol Stool Form Scale)(Measured at enrollment into treatment phase, and after 4, 8, 12, 24 , and 36 weeks of treatment.)
- IBS-Quality of Life Measure (IBS-QOL)(Measured at enrollment into treatment phase, and after 12, and 36 weeks of treatment.)
- Changes of Emotional Suppression (Courtauld Emotional Control Scale, CECS)(Measured at enrollment into treatment phase, and after 12, and 36 weeks of treatment.)