A Prospective, Interventional, Randomized, Parallel, Double blind, Multicenter, Placebo controlled, Clinical Study to evaluate the efficacy and safety of Bacillus Coagulans BCP92 (MTCC 25460) in adults with irritable bowel syndrome.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- DSFQ on 5-point Likert scale.
研究概览
简要总结
Irritable bowel syndrome (IBS) is one of the most diagnosed gastrointestinal diseases. IBS, in the absence of any other causative disease, is defined as the presence of abdominal pain or discomfort with altered bowel habits. It is estimated to affect 10%-15% of the Western population and has a large impact on quality of life and direct healthcare costs.Probiotics may influence the IBS symptoms including abdominal pain, bloating, distension, flatulence, altered bowel movements, and gut microbiota.Probiotics also amplify the intestinal tight junctions and stabilize the permeability. Moreover, probiotics stimulate goblet cells to produce mucus to enhance the intestinal barrier function, normalize bowel movements, and reduce visceral hypersensitivity in pediatric and adult patients.Based on data from our previous two studies, we hypothesized that a use of Bacillus Coagulans BCP92 in patients with Irritable when given in sufficient amounts confer a health benefit on the host, assist in the management of dysbiosis and or stabilization of the host microbiota in IBS.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Good Physical and medical condition assessed based on the patient history and physical condition. 2.Laboratory test results(complete blood count blood chemistry panel) within normal limits or considered not to be clinically significant by the investigator and negative SARS COV 2 antibody test.
- •A voluntary provided written informed consent.
- •Diagnosis of IBS based on the ROME IV criteria e.g., recurrent abdominal pain at least one day a week for the last three months, associated with two or more of the following symptoms (these should be present for the last three months, with the onset of symptoms six months before diagnosis e.g.recurrent abdominal pain at least one day a week for the last three months, associated with two or more of the following symptoms (these should be present for the last three months, with the onset of symptoms six months before diagnosis. a. related to defecation. b. associated with a change in stool frequency and/or c. associated with a change in stool form (appearance) 5.Patients with any of the following forms of IBS will be included. a. IBS-D.
- •more than 50% of BSF type 6 and 7 stools, and less than 25% of type 1 and 2 stools. b. IBS-C.
- •more than 50% of BSF type 1 and 2 stools, with less than 25% of type 6 and 7 stools. 6.At least moderate symptom severity defined as an IBS-SSS score of >175 (5 items, maximum score 500). 7.The following medications are allowed during this study, provided they have been used at a stable dose and for at least 1 month prior to the study a. Contraceptive pills or intramuscular contraceptives, b. Hormone replacement therapy (estrogen/progesterone), c. L-thyroxine. d. Antidepressants at low doses (up to 25 mg of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor per day) e. Antihypertensives at low doses (diuretics, angiotensin converting enzyme inhibitors f. Angiotensin receptor antagonists.
排除标准
- •Exclusion Criteria: Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria: 1.Unclassified IBS.
- •2.Cardiovascular disorders: uncontrolled hypertension (blood pressure >170/100 mmHg), cerebrovascular disease.
- •3.Respiratory disorders (asthma, chronic obstructive pulmonary disease [COPD].
- •4.Hepatic impairment (including status post cholecystectomy), renal impairment, and unexplained blood biochemistry abnormalities: serum creatinine levels over twice the upper limit of normal, AST or ALT levels over twice the upper limit of normal.
- •5.Gastrointestinal conditions other than IBS, including clinical or endoscopic diagnosis of gastroenteritis.
- •6.Endocrine disorders, including diabetes mellitus (fasting blood glucose >11 mmol/L) and elevated TSH levels.
- •7.Severe neurological conditions, with psychosis.
- •8.Malignancy.
- •9.Pregnancy or breastfeeding.
- •10.Hypersensitivity to Study Product 11.Lactose intolerance.
- •12.The use of gastrointestinal motility stimulants or dietary fiber supplements during the 2 weeks preceding the clinical study.
- •13.The use of antithrombotic drugs.
- •14.Any surgical procedure scheduled during the clinical study.
- •15.Current probiotic use and refusal to undergo a 3-month washout period.
- •17.Being included in another clinical study during the previous 3 months.
结局指标
主要结局
DSFQ on 5-point Likert scale.
时间窗: Time Frame would be of 4 Weeks,8 Weeks and 12 Weeks.
1.Changes in severity of IBS symptoms using IBS Severity Scoring System.
时间窗: Time Frame would be of 4 Weeks,8 Weeks and 12 Weeks.
2.Improvement or worsening of IBS global symptoms using Global Improvement Scale.
时间窗: Time Frame would be of 4 Weeks,8 Weeks and 12 Weeks.
4.Assessment of change in Gastrointestinal symptoms frequency assessment using
时间窗: Time Frame would be of 4 Weeks,8 Weeks and 12 Weeks.
3.Changes in an absolute relief.
时间窗: Time Frame would be of 4 Weeks,8 Weeks and 12 Weeks.
5.Assessment of change in stool consistency using Bristol stool chart.
时间窗: Time Frame would be of 4 Weeks,8 Weeks and 12 Weeks.
6.Change in IL-6.
时间窗: Time Frame would be of 4 Weeks,8 Weeks and 12 Weeks.
次要结局
- 1.Change in IBS-related mental stress relief as assessed by Perceived Stress Scale((PSS).)