Comparing the Effectiveness of Two Diets to Control the Symptoms of Irritable Bowel Syndrome With Diarrhea (IBS-D): a Randomized, Controlled Trial and Gastrointestinal Microbiome Analysis
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
- Proportion of patients with adequate relief.
研究概览
简要总结
The purpose of the study is to find out if the diets often recommended for patients with Irritable Bowel Syndrome with diarrhea (IBS-D) provide adequate relief. The study will compare two diets that are used to treat IBS-D symptoms to see which one is more effective. The study will also measure the effect of these diets on the bowel flora, which are the good bacteria that inhabit the bowels in healthy people.
详细描述
As irritable bowel syndrome (IBS) symptoms are often refractory to conventional therapies, there has been increasing interest in the role of diet in IBS. Certain foods may exacerbate symptoms of IBS. Thus, restricted diets have recently gained attention for the treatment IBS. The mechanism by which symptoms are improved is unclear, but these diets may improve symptoms by exerting changes on the GI microbiome.
Aims:
Primary Objective:
-Compare the proportion of patients with irritable bowel syndrome (IBS-D) reporting adequate relief on Diet 1 vs Diet 2
Secondary Objectives:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet Rome III criteria for IBS as assessed by a gastroenterologist:
- •Fulfill the Rome III stool consistency criteria for IBS -D
- •Willingness to maintain a stable dosage of IBS medications during the pretreatment baseline period, including tricyclic antidepressants; "rescue" medications permitted (ie Loperamide 2mg up to 4 times per day prn diarrhea)
- •Ability to provide written informed consent for study participation
- •Capable of independently completing all requirements of the study including returning for required visits
- •Documentation of normal colonoscopy with colon biopsies within five years
- •Documentation of normal TSH, CBC, electrolyte panel
- •Negative evaluation for celiac disease either with normal TTG, EMA, and/or duodenal biopsy.
排除标准
- •Unable to understand or provide written informed consent
- •Pregnancy
- •IBS with constipation or mixed subtype
- •Comorbid medical problems that may affect gastrointestinal transit or motility:
- •Inflammatory bowel disease
- •Extraintestinal disease known to affect the gastrointestinal system (ie, scleroderma, unstable thyroid disease, diabetes mellitus, etc.)
- •Severe renal or hepatic disease
- •Previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery
- •Previous treatment with some diets for IBS
- •Concurrent medications not permitted including probiotics, antibiotics, and narcotics
- •Active participation in another form of dietary therapy
- •Patients who have undergone surgery to the GI tract except appendectomy or cholecystectomy if performed more than six months prior to enrollment.
研究组 & 干预措施
Diet 1
Patients randomized to this arm will receive both written and face-to-face advice about how the components of Diet 1 can be used to control their IBS symptoms.
干预措施: Dietary intervention (Other)
Diet 2
Patients randomized to this arm will receive both written and face-to-face advice about how the components of Diet 2 can be used to control their IBS symptoms.
干预措施: Dietary intervention (Other)
结局指标
主要结局
Proportion of patients with adequate relief.
时间窗: 4 weeks
Compare the proportion of patients with irritable bowel syndrome (IBS-D) reporting adequate relief on Diet 1 v Diet 2.
次要结局
- Composite endpoint(4 weeks)
- Abdominal Pain(4 weeks)
- Individual symptoms(4 weeks)
- Quality of life measures(4 weeks)
- Stool Microbiome(4 weeks)
- Serum Biomarker Panel(4 weeks)
- Stool consistency(4 weeks)
- Stool frequency(4 weeks)
研究者
Shanti Eswaran
Clinical Assistant Professor
University of Michigan