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临床试验/NCT05523427
NCT05523427已完成不适用

Two Lactobacilli Strains as Adjuvant Therapy in the Management of Irritable Bowel Syndrome: A Randomized Clinical Trial

University of Mosul2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
The change in bowel habits (based on the IBS-SSS) after treatment with a multi-strain probiotic or standard treatment, and compared with baseline.

研究概览

简要总结

Studying the effects of adding probiotics to the drug regimen of patients with diarrhea predominant IBS

详细描述

Irritable bowel syndrome (IBS) is a common highly prevalent functional gastrointestinal (GI) disorder that places an enormous burden on resource-challenged healthcare systems. Although many drugs have been advocated in the treatment of IBS, including psychotropic agents, antispasmodics, bulking agents, and 5-HT receptor antagonists. However, in the vast majority of instances, these medications have failed to provide adequate symptom alleviation, presumably due to the disease's diverse pathophysiology. Probiotics are "live bacteria that confer a health benefit on the host when administered in suitable doses". In IBS, a decrease in Bifidobacterium and Lactobacillus species, as well as an increase in Gamma-proteobacteria species (a family of pathogens), has been described in IBS studies. Therefore, the ability of probiotics to repair dysbiosis (qualitative and quantitative changes in the microbiota) or stabilize the host microbiota is the reason for their use in the treatment of IBS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
16 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Both genders
  • Patients diagnosed clinically with IBS based on Rome's criteria
  • IBS-Diarrhea only with pain & distention
  • Duration of symptoms 6 months

排除标准

  • Celiac disease
  • Inflammatory bowel disease (ulcerative colitis & Crohn's)
  • Thyroid disease
  • Lactose intolerance
  • Alarming features (anemia, blood in the stool, weight loss, abdominal masses, dysphagia, family history of GIT malignancy)
  • Preexisting use of antibiotics in the previous 3 months.
  • Preexisting systemic diseases

结局指标

主要结局

The change in bowel habits (based on the IBS-SSS) after treatment with a multi-strain probiotic or standard treatment, and compared with baseline.

时间窗: Three months

The change in severity of abdominal pain and distention, frequency of bowel motion, satisfaction with bowel habits, and IBS-related quality of life (QoL).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Radhwan Al-Zidan

Lecturer

University of Mosul

研究点 (2)

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