CTRI/2020/07/026720尚未招募不适用
A prospective, randomized, double-blind, placebo-controlled parallel-group clinical trial to evaluate the effects of a Bacillus coagulans-based product in patients with IBS-Diarrhea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Difference in the overall symptoms relief between the intervention group and the placebo group as assessed by IBS-SSS
研究概览
简要总结
Irritable bowel syndrome (IBS) is a chronic gastrointestinaldisorder involving abdominal pain or discomfort and alterations in bowel habit(frequency, form, and passage).1,2 The prevalence of IBS in the United Statesvaries widely because of the use of different diagnostic criteria and survey methods.The 2 most recent surveys reported a total prevalence of 7% to 14%, with ahigher prevalence in women.3,4 Although IBS is not life threatening, thesymptoms of IBS can have a profound impact on the patient’s emotional healthand quality of life.
Abode Biotec India Private Limitedhas developed the probiotic strain (Bacilluscoagulans) called ProBCPlus which is a well-studied strain of lacticacid-producing bacteria that can sustain the low pH of stomach acid and becomeactive in the intestine.21,22.
The current study is designed andwill be conducted to evaluate the effect of 8 weeks supplementation of ProBCPlus inIBS-D subjects (defined by Rome III criteria) on IBS-D prominent symptoms(abdominal pain and other GI- related symptoms, stool consistency andfrequency) and lipid profile.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female 2.
- •65 years old 3.Signed informed consent 4.IBS-Diarrhea patient satisfying Rome III criteria. oRecurrent abdominal pain or discomfort, 3 days per month in the last 3 months (12 weeks), associated with ≥ 2 of the criteria below. The criteria are fulfilled with symptoms onset 6 months prior to diagnosis:.
排除标准
- •The patient will be excluded from the study if assessment by the treating investigator showed an evidence for cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, head, ears, eyes, nose and throat, dermatologic/psychiatric, allergy, major surgery or other diseases as revealed by history, physical examination and existing laboratory assessments which may interfere with the administration.
- •2.Pregnant or lactating women.
- •3.Females at childbearing age will be excluded unless they are using acceptable birth control measures (i.e. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices, sexual abstinence or a vasectomized partner).
- •4.Patients requiring treatments with non-permitted medication (i.e. 5-HT3 antagonist, spasmolytics, anticholinergics, cholestyramine, anti flatulence agents, metoclopramide, gastric-anti secretory agents (proton pump inhibitors; for indications other than Gastroesophageal Reflux Disease (GERD)), narcotics, anti-diarrheal drugs, and systemic steroids) 5.Patients requiring the use of antibiotics either in medicine form of natural (e.g. grapefruit seed extract, olive leaf extract, oil of oregano, colloidal silver and highly concentrated garlic preparations)
- •Exercise and the use of complementary and alternative medicine for IBS symptoms (i.e. peppermint oil, cognitive behavior therapy) during the study should be maintained at the same level prior to the study.
- •7.Patients exceeding the treatment limits of permitted medication [(more than 2 days/week during the study period): alginate, antacids and analgesics (limited to acetaminophen ≤ 1000 mg/day, acetylsalicylic acid or NSAIDS no more than 2 tablets/day), (stable dose throughout the study period, anti-depressants (must be on a stable dose > 3 months), fiber supplements, psyllium hydrophilic mucilloid, gastric anti secretory agents (only for GERD patients who are on a stable dose > 3 months; patients should be able to differentiate between IBS and GERD symptoms), acetylsalicylic acid ≤ 325 mg/day, sedatives.
- •Deliverance medications: Mild laxatives only if necessary.].
- •Any other medications can be used without limits based on the clinical judgment of the treating investigator.
- •8.Being in another clinical trial 4 weeks before entering the study 9.Constipated IBS patients 10.IBS-Diarrhea patients with un-treated lactose intolerance 11.Regular use of probiotics or using other probiotics during the course of the study 12.Patients allergic to milk or soy products 13.Patients using catheters 14.Patients presented with rectal bleeding, weight loss, iron deficiency anemia, nocturnal symptoms and a family history of colorectal cancer, inflammatory bowel disease and celiac spruce 15.Patients over 50 diagnosed with Irritable Bowel Syndrome who have not had a colonoscopy in the last 5 years 16.Patients who have allergies for the active ingredients or any of the excipients 17.Patients presented with any immune-compromised condition (such as AIDS, lymphoma, long term corticosteroid treatment) Patients presented with nausea, vomiting and fever.
结局指标
主要结局
Difference in the overall symptoms relief between the intervention group and the placebo group as assessed by IBS-SSS
时间窗: Time Frame 8 weeks
次要结局
- Differences in stool consistency and frequency/ day between the intervention group and the placebo group over the study period. Differences in hematological parameters and lipid profile biomarkers between the intervention group and the placebo group over the study period.
研究者
研究点 (1)
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