Multicentric, Phase IV, randomized, double blind, placebo controlled trial to assess effectiveness and safety of Lactobacillus acidophilus LA-5® and Bifidobacterium BB-12® in the treatment of Non-Constipated Irritable Bowel Syndrome in adults aged 18 years to 65 years.
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- To determine the effectiveness of 12 weeks consumption of Lactobacillus acidophilus, LA-5® and Bifidobacterium animalis ssp. lactis, BB-12® on the abnormal defecation and abdominal pain and discomfort in non-constipated IBS patients.
研究概览
简要总结
This study proposes to add to the existing literature from clinical trials that have established that changes in intestinal microflora with different therapeutic approaches, such as the use of prebiotics, probiotics, synbiotics, and nonabsorbable and systemic antibiotics prove effective in symptom alleviation in IBS. The objectives of the study are to determine the effectiveness of 12 weeks consumption of Lactobacillus acidophilus, LA-5® and Bifidobacterium animalis ssp. lactis, BB-12® on the abnormal defecation and abdominal pain and discomfort in non-constipated IBS patients. Secondary objective is to determine the effects of 12 weeks consumption of Lactobacillus acidophilus, LA-5® and Bifidobacterium animalis ssp. lactis, BB-12® on health-related quality of life using the questionnaires IBS-QoL EAR3Q and IBS-SSS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects in the age group of 18-65 years (both ages inclusive) with a positive diagnoses of non-constipated IBS ) diagnosed based on responses to the Enhanced Asian ROME 3 Questionnaire
- •Criteria fulfilled for the last 3 months with symptom onset at least 6 months before study.
- •Able to provide signed informed consent and be able to comply with study procedures.
排除标准
- •1.Subjects with Constipation Predominant IBS (IBS-C) 2.Subjects with history of major abdominal surgery, a history of inflammatory bowel disease or diverticular disease, celiac disease, structural abnormalities of the gastrointestinal tract other than oesophagitis or gastritis allergic diseases.
- •3.Other organic or major psychiatric disorders such as schizophrenia manic depressive conditions as assessed by medical history, appropriate consultations and laboratory tests.
- •4.Faecal occult blood test positive 5.Pregnant or Lactating mothers 6.Any other medical condition in the opinion of the investigator rendering the subject ineligible to participate.
- •7.Use of antibiotics or probiotics in the three weeks preceding study start.
结局指标
主要结局
To determine the effectiveness of 12 weeks consumption of Lactobacillus acidophilus, LA-5® and Bifidobacterium animalis ssp. lactis, BB-12® on the abnormal defecation and abdominal pain and discomfort in non-constipated IBS patients.
时间窗: •Number and proportion of responders in each arm who experience improvement in symptoms recorded by IBS Global Improvement Scale (IBS-GIS): | •A responder defined as a patient who answered that their symptoms were either “moderately improved†or “substantially improvedâ€. The weekly numerical evaluation of abdominal pain from baseline to treatment end of 12 weeks as defined in the daily symptom diary
次要结局
- To determine the effects of 12 weeks consumption of Lactobacillus acidophilus, LA-5® and Bifidobacterium animalis ssp. lactis, BB-12® on health-related quality of life using the questionnaires IBS-QoL EAR3Q and IBS-SSS.(Numerical evaluation of changes in scales from baseline to treatment end of 12 weeks.)