CTRI/2023/01/048644尚未招募Unknown
A prospective, randomized, double-blind, placebo-controlled parallel-group clinical trial to evaluatethe effects of a Bacillus coagulans-based product in patients with IBS-Diarrhea
试验速览
- 阶段
- Unknown
- 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
研究概览
简要总结
Irritable bowel syndrome (IBS) is a chronicgastrointestinal disorder involving abdominal pain or discomfort andalterations in bowel habit (frequency, form, and passage).1,2 The prevalence ofIBS in the United States varies widely because of the use of differentdiagnostic criteria and survey methods. The 2 most recent surveys reported atotal prevalence of 7% to 14%, with a higher prevalence in women.3,4 AlthoughIBS is not life threatening, the symptoms of IBS can have a profound impact onthe patient’s emotional health and quality of life. Irritable bowel.
研究设计
- 研究类型
- Observational
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.
排除标准
- •1.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.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.
结局指标
主要结局
Difference in the overall symptoms relief
时间窗: 8 weeks
between the intervention group and the placebo
时间窗: 8 weeks
group as assessed by IBS SSS
时间窗: 8 weeks
次要结局
- 1.Difference in hematological parameters and lipid profile biomarkers in-between 2 groups over the study period.(2.Differences in stool consistency and frequency per day in-between 2 groups over the study period)
研究者
研究点 (1)
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