NCT05149599已完成1 期
Efficacy and Safety of Saccharomyces Cerevisiae for Abdominal Pain and Discomfort in Irritable Bowel Syndrome (IBS) Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with Irritablebowel syndrome through pain/ discomfort score
研究概览
简要总结
This study is designed to see the response of saccharomyces cerevisiae for symptomatic improvement of patients with IBS
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between 18 and 75 years of age,
- •Patients having confirmed IBS according to Rome IV criteria (newly and previously non-responder to treatment),
- •Pain/ discomfort score strictly above 1 and strictly below 6 as determined on a pain/ discomfort scale using arbitrary grading from 0 to 7 in 7 days preceding the inclusion visit,
- •Not hypersensitive to any of the ingredients of the drug.
排除标准
- •Patients with an organic intestinal disease (Crohn's disease, ulcerative colitis, etc.),
- •Pregnant females
- •Treatments likely to influence IBS (anti-depressants, opioids, and narcotic analgesics)
- •Patients with chronic alcoholism, vegetarian or vegan regimens
- •Eating disorders such as anorexia or bulimia
- •Documented food allergies.
研究组 & 干预措施
Treated patients
Experimental
干预措施: Saccharomyces cerevisiae (Drug)
结局指标
主要结局
To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with Irritablebowel syndrome through pain/ discomfort score
时间窗: One month
Responders were defined as the patients who had an improvement of 50% of the weekly average intestinal pain/discomfort score compared with the baseline average score for at least 2 out of the 4 weeks of study duration
次要结局
- To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with IBS through IBS quality of life questionnaire(One month)
研究者
DR MEHREEN SIYAL
Resident Gastroenterology
Ziauddin University
研究点 (1)
Loading locations...
相似试验
终止
不适用
Effect of Saccharomyces Cerevisiae on Vulvo-vaginal CandidiasisCandidiasis, VulvovaginalNCT02859493Lesaffre International80
已完成
不适用
The efficacy evaluation of Saccharomyces cerevisiae SM-10 on the jointsHealthy adultJPRN-UMIN000022740TTC CO., LTD.60
终止
不适用
Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal CandidiasisVulvo-vaginal CandidiasisNCT02345096Lesaffre International22
Unknown
不适用
Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn DiseaseCrohn DiseaseUlcerative ColitisNCT03941418University Clinic Dr Dragisa Misovic-Dedinje150
招募中
3 期
The effect of Saccharomyces Cerevisiae enriched with selenium and mineral selenium on postpartum depression and sexual satisfactioIRCT20110606006709N23Tabriz University of Medical Sciences108