A Multicenter Real-World, Single-Arm, Open-Label Study Assessing the Impact of Novel Probiotic Mixture on the Symptoms of Irritable Bowel Syndrome in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,098
- 试验地点
- 2
- 主要终点
- abdominal pain
研究概览
简要总结
Irritable bowel syndrome (IBS) is faced by gastroenterologists on a daily basis and probiotics are a potential therapeutic tool, however, there is no strain recommendations. This multicenter re-al-world, single-arm, open-label study aims to assess the effectiveness, safety, and patient satis-faction of a novel probiotic mixture in patients with IBS. Methods: This study is conducted by Italian gastroenterologists who enroll patients with IBS. Throughout the 8-week treatment (T1) period with a probiotic mixture (Lactobacillus paracasei 101/37 LMG P-17504, Lac-tobacillus plantarum 14D CECT 4528, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve BL10 LMG P-17500, and Bifidobacterium animalis ssp. lactis Bi1 LMG P-17502), participants complete a questionnaire to evaluate IBS symptoms at baseline, at the end of treatment, and after one-month follow-up (T2).
详细描述
Irritable bowel syndrome (IBS) is faced by gastroenterologists on a daily basis and probiotics are a potential therapeutic tool, however, there is no strain recommendations. This multicenter re-al-world, single-arm, open-label study aims to assess the effectiveness, safety, and patient satis-faction of a novel probiotic mixture in patients with IBS. Methods: This study is conducted by Italian gastroenterologists who enroll patients with IBS. Throughout the 8-week treatment (T1) period with a probiotic mixture (Lactobacillus paracasei 101/37 LMG P-17504, Lac-tobacillus plantarum 14D CECT 4528, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve BL10 LMG P-17500, and Bifidobacterium animalis ssp. lactis Bi1 LMG P-17502), participants complete a questionnaire to evaluate IBS symptoms at baseline, at the end of treatment, and after one-month follow-up (T2).
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recurrent abdominal pain at least once per week during the past three months associated with two or more of the following criteria:
- •related to defecation,
- •Associated with a change in the frequency of stool,
- •Associated with a change in the appearance of stool.
排除标准
- 未提供
结局指标
主要结局
abdominal pain
时间窗: After 8 weeks of probiotic supplementation and after 4 weeks of follow-up
abdominal pain severity. The questionnaire utilized a 5-point Likert scale, where 0 represented the absence of symptoms, and 5 indicated the presence of highly intense symptoms. Treatment success will be defined as a change towards categories of lower IBS severity for abdominal pain and/or bloating 149 between inclusion (T0) and the end of the supplementation period (T1)
bloating
时间窗: After 8 weeks of probiotic supplementation and after 4 weeks of follow-up
bloating severity. The questionnaire utilized a 5-point Likert scale, where 0 represented the absence of symptoms, and 5 indicated the presence of highly intense symptoms. Treatment success will be defined as a change towards categories of lower IBS severity for abdominal pain and/or bloating 149 between inclusion (T0) and the end of the supplementation period (T1).
次要结局
未报告次要终点
研究者
Ruggiero Francavilla
Prof
University of Bari