A Prospective, Randomized, Double-Blind, Placebo-controlled, Parallel Group-Clinical trial to evaluate the effects of Bacillus Clausii based product in patients with IBS-Diarrhea
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Reduction in the severity and frequency of abdominal pain, assessed.
研究概览
简要总结
IBS is a functional bowel disorder characterized by symptoms of abdominal pain or discomfort and associated with disturbed defecation. The symptoms of IBS have a physiological basis. Although no specific physiological mechanism is unique to, or characterizes IBS, there are at least 3 interrelated factors that affect symptoms to varying degrees in individuals with IBS: (1) altered gut reactivity (motility, secretion) in response to luminal (e.g., meals, gut distention, inflammation, bacterial factors) or provocative environmental (psychosocial stress) stimuli, resulting in symptoms of diarrhea and/or constipation; (2) a hypersensitive gut with enhanced visceral perception and pain; and (3) dysregulation of the brain-gut axis, possibly associated with greater stress-reactivity and altered perception and/or modulation of visceral afferent signals.
Nearly 12 percent of patients seek medical care in primary care practices for IBS related complaints. Studies have demonstrated that the prevalence of IBS ranges between ten and fifteen percent; however, the majority of these patients do not seek medical care. IBS is most prevalent in South America at approximately 21 percent and least prevalent in Southeast Asia at 7 percent. In the United States, Canada, and Isreal, IBS symptoms are 1.5 to 2 times more prevalent among women than men. Moreover, women are more likely to report abdominal pain and constipation, whereas men are more likely to report diarrhea. The prevalence of IBS also decreases with age. IBS can also be broken down into more specific diagnoses, which include IBS with diarrhea (IBS-D), IBS with constipation (IBS-C), and IBS with mixed bowel patterns (IBS-M). The prevalence of these three diagnoses differs in the United States versus Europe. In the United States, there is an equal distribution of these diagnoses, whereas, in Europe, IBS C or IBS-M can be more prevalent
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 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
- •Male and female subjects aged between 18 and 60 years.
- •Subjects presenting with acute diarrhea, defined as the occurrence of three or more loose stools per day for a duration of less than 72 hours, accompanied by clinical symptoms such as bloating, abdominal pain, or other related gastrointestinal discomfort.
- •Subjects must meet the Rome IV criteria for mild to moderate IBS-D, characterized by recurrent abdominal pain occurring, on average, at least one day per week in the last three months, with symptom onset at least six months prior to diagnosis.
- •The condition must also be associated with at least two of the following: a) Symptoms related to defecation b) Onset of symptoms associated with a change in stool frequency c) Onset of symptoms associated with a change in stool form (appearance)
- •Subjects must present with stool types classified as Type 6 or Type 7 on the Bristol Stool Chart, indicating the presence of loose or watery stools, suggestive of gastrointestinal disturbances such as diarrhea.
- •Subjects must not have any severe health conditions that could significantly affect gut health, including major gastrointestinal disorders that may confound study outcomes.
- •Subjects must demonstrate the ability and willingness to provide written informed consent for participation in the study.
排除标准
- •1.Patients requiring the use of antibiotics either in medicine form of natural e.
- •grapefruit seed extract, olive leaf extract, oil of oregano, colloidal silver and highly concentrated garlic preparations.
- •2.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.
- •The patient will be excluded from the study if assessment by the treating investigator showed 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.
- •3.Pregnant or lactating women.
- •4.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.
- •5.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.
- •Patients exceeding the treatment limits of permitted medication more than 2 days per week during the study period: alginate, antacids and analgesics limited to acetaminophen less than or 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 antisecretory 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 less than or equal to 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.
- •Being in another clinical trial 4 weeks before entering the study.
- •8.Constipated IBS patients.
- •IBS-Diarrhea patients with un-treated lactose intolerance.
- •Regular use of probiotics or using other probiotics during the study.
- •Patients are allergic to milk or soy products.
- •Patients using catheters.
- •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.
- •Patients who have allergies for the active ingredients or any of the excipients
- •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
Reduction in the severity and frequency of abdominal pain, assessed.
时间窗: Day 1;Day 30; Day 60
2. Improvement in stool consistency as measured by the Bristol Stool
时间窗: Day 1;Day 30; Day 60
Chart, with a shift towards normal stool types (Types 3–5),
时间窗: Day 1;Day 30; Day 60
evaluated across both groups.
时间窗: Day 1;Day 30; Day 60
3. Improvement in patient-reported overall symptom relief, assessed
时间窗: Day 1;Day 30; Day 60
using a standardized IBS symptom questionnaire, with comparative
时间窗: Day 1;Day 30; Day 60
analysis between the two groups.
时间窗: Day 1;Day 30; Day 60
using a validated pain intensity scale (Visual Analog Scale),
时间窗: Day 1;Day 30; Day 60
comparing outcomes between the intervention and placebo groups
时间窗: Day 1;Day 30; Day 60
次要结局
- 1.Incidence of adverse events (AEs) and serious adverse events((SAEs) throughout the study duration, compared between the)
研究者
Bhimaray Katageri
Shri. B. M. Patil Medical College, Hospital & Research Centre