A double blind, randomized, placebo-control study to evaluate the effect of Bacillus coagulans supplementation in management of symptoms of IBS.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 1.Reduction of abdominal discomfort / pain intensity – assessed by physician (Baseline and Week 6, Week 10, and Week 12)
研究概览
简要总结
To investigate effect of UBLAC (Bacillus coagulans Unique IS2 - Probiotic) supplementation versus placebo on Irritable Bowel Syndrome subjects for the management of symptoms in subjects, in a double-blind, randomized controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects of either sex having age group 18-60 years.(Both inclusive) 2.Must include all of the following criteria, (Rome III Criteria) A.
- •Abdominal discomfort or pain associated with two or more of the following at least 25% of the time: a)Improvement with defecation b)Onset associated with a change in frequency of stool c)Onset associated with a change in the form (appearance) of stool B.
- •No evidence of an inflammatory, anatomic, metabolic or neoplastic process that explains the subject’s symptoms 3.Weekly average of the worst daily (in the past 24 hours) abdominal pain score of ≥ 3.0 on a 11 point scale.
- •4.An average of fewer than 3 CSBMs per week.
- •CSBM is defined as a bowel movement, not resulting from use of laxatives that is associated with a sensation of completeness.
- •5.Able to provide informed consent.
排除标准
- •Participants with a BSS (Bristol Stool Scale) score of 7 (watery, no solid pieces) or 6 (fluffy pieces with ragged edges, a mushy stool) for > 25 % of their BMs during the 12 weeks before screening or, during the run-in period.
- •This does not include BMs that were induced by the use of laxatives.
- •Patients presenting any disease that may affect bowel motility other than the clinical diagnosis of IBS.
- •Presence of rectal bleeding, recent weight loss (greater than 5 kg in the past month) or iron deficiency anemia.
- •History of lactose intolerance and other malabsorption syndromes (e.g. fructose malabsorption).
- •Previous abdominal surgery and patients suffering from severe systemic disease.
- •Pregnant or breast-feeding or planning on becoming pregnant.
- •Women of child-bearing potential not using effective contraception.
- •Use of any antibiotic drugs (e.g., neomycin, rifaximin) within 1 month of screening.
- •Daily use of laxative within 1 month of screening.
- •Current use, or use within the past 3 months, of narcotics or other medications for IBS symptom management (e.g. alosetron, tegaserod, lubiprostone, antispasmodics, antidiarrheals).
结局指标
主要结局
1.Reduction of abdominal discomfort / pain intensity – assessed by physician (Baseline and Week 6, Week 10, and Week 12)
时间窗: 1.Reduction of abdominal discomfort / pain intensity – assessed by physician (Baseline and Week 6, Week 10, and Week 12) | 2. An increase of at least one complete spontaneous bowel movement per week from baseline; during the same week, for at least 4 out of 8 weeks of the intervention period.
2. An increase of at least one complete spontaneous bowel movement per week from baseline; during the same week, for at least 4 out of 8 weeks of the intervention period.
时间窗: 1.Reduction of abdominal discomfort / pain intensity – assessed by physician (Baseline and Week 6, Week 10, and Week 12) | 2. An increase of at least one complete spontaneous bowel movement per week from baseline; during the same week, for at least 4 out of 8 weeks of the intervention period.
次要结局
- 6. Evaluation of serum cytokines- Tumor necrosis factor alpha (TNF α), Interferon gamma (IFN γ), Interleukin 6 (IL- 6), Interleukin 10 (IL-10) and Interleukin 12 (IL-12)(6.Baseline, Week 10)
- 1.Overall change in severity of symptoms (Baseline, Week 6, Week 10)(2.Abdominal discomfort (Baseline, Week 6, Week 10))