Rifaximin Therapy Versus Low FODMAP Diet In Irritable Bowel Syndrome: A Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of subjects with adequate relief of composite of abdominal symptom (pain/discomfort) and stool symptom (frequency/ consistency) after treatment.
研究概览
简要总结
Functional gastrointestinal disorders (FGIDs) are common and from the most recent global epidemiology study, an estimated 40% of the world population suffer from the condition. FGIDs cause significant morbidity to patients, despite not influencing mortality. IBS is among the most important functional gastrointestinal disorder with an estimated 3.8 to 9.2 % of the general population worldwide were affected by this disorder.
Rifaximin (gut specific antibiotic) and low FODMAP diet (dietary based therapy) were proven to be effective in treating irritable bowel syndrome (IBS), however there was no head-to-head study comparing both treatments. This study will help doctors to understand the efficacy of different IBS/SIBO treatments. With the evaluation of factors that can predict treatment response, doctor could potentially treat IBS and SIBO more effectively in future.
The purpose of the study is to compare the clinical symptoms and psychological improvement in patients with irritable bowel syndrome (IBS) after treatment with Rifaximin versus treatment with low FODMAP diet. The factors that is associated with treatment response will also be evaluated. In IBS patients with small intestinal bacterial overgrowth (SIBO), eradication rate of SIBO will be evaluated.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Irritable bowel syndrome using Rome III diagnostic criteria with Abdominal Pain/ Discomfort Intensity of weekly average of worst abdominal pain/ discomfort in past 24 hours score of ≥ 3.0 on a 0 to 10 point scale AND Stool Consistency of at least 2 days per week with at least one stool that has a consistency of Type 6 or Type 7 BSS or <3 CSBM per week
- •Subject who can provide written informed consent and willingness to comply with the requirement of the protocol
- •Able to communicate in English, Malay, or Mandarin languages
排除标准
- •Patients with known hypersensitivity or contraindication to Rifaximin
- •Pregnant / breastfeeding women
- •Patients who are on probiotics for the past 1 month
- •Presence of family history of GI malignancy or alarm features suggested malignancy - e.g. Unintentional weight loss (≥ 10% of body weight in recent 6 months), GI bleeding
- •History of gastrointestinal (GI) malignancy
- •Patients with any hepatobiliary or pancreatic diseases
- •Patients with severe depression, anxiety, or other psychological disorder
- •Patients with any terminal disease
- •Other conditions determined by the investigator to be inappropriate for this clinical study
研究组 & 干预措施
Antibiotics
干预措施: Rifaximin (Drug)
Dietary based therapy
干预措施: Low FODMAP diet (Other)
结局指标
主要结局
Proportion of subjects with adequate relief of composite of abdominal symptom (pain/discomfort) and stool symptom (frequency/ consistency) after treatment.
时间窗: 4 weeks
Adequate relief was defined as self-reported relief of both symptoms (abdominal symptom and stool symptom) at least in week 2 or 4. (Subjects will be provided with self-reported questionnaires for week 2 and 4). For IBS-D, relief was defined as a decrease of at least 30% from baseline in weekly mean ratings of IBS-related abdominal pain or discomfort and a weekly decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. For IBS-C, relief was defined as a decrease of at least 30% from baseline in weekly mean ratings of IBS-related abdominal pain or discomfort and an increase of 1 or more complete spontaneous bowel movement (CSBM) per week compared with baseline. For IBS-M, relief was defined as fulfilled both IBS-D and IBS-C symptom relief criteria.
次要结局
- Proportion of patients who had relief was determined from the patients' weekly assessments of global IBS symptoms, bloating, abdominal pain/ discomfort, and stool consistency/ frequency after treatment with Rifaximin or low FODMAP diet(4 weeks)
- Symptom severity score improvement(4 weeks)
- Proportion of patients with SIBO who had eradication of SIBO after treatment(6 weeks)
- Assessment of factors that were associated with treatment response(6 weeks)
- Change in Health-Related Quality of Life (HRQOL) score(4 weeks)
研究者
Dr. Chuah Kee Huat
Medical Lecturer and Clinical Specialist
University of Malaya