Effectiveness of the Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Inflammatory blood markers
研究概览
简要总结
A three month follow-up study to evaluate the effectiveness of a tailored anti-inflammatory eating plan guided by a registered dietitian to treat irritable bowel syndrome.
详细描述
This study will have 60 participants with Irritable bowel syndrome (IBS) for a duration of three months. The procedures will consist of anthropometric measures, blood pressure, questionnaires, and a blood sample. There will be seven visits with one including a virtual meeting with a registered dietitian involved in the Lifestyle Eating and Performance (LEAP) program. With these procedures the investigators will test the effectiveness of the LEAP program for the treatment of irritable bowel syndrome by improving inflammatory markers, symptoms, and quality of life.
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
- •Adult patients with an established diagnosis of IBS-D as determined by Rome III or IV Criteria
- •Have IBS of at least moderate severity
- •Must be on a stable dose regimen for at least 1 month prior to enrollment
- •Willing to follow the LEAP program for 3 months
- •Able to give informed consent
- •Willing to complete the study
排除标准
- •Individuals with a history of inflammatory bowel disease, celiac disease, abdominal surgeries, cancer patients under treatment, and kidney failure
- •BMI of 40 or higher
- •Pregnancy or planned pregnancy or lactation
- •Any serious illness that will interfere with the study procedures or results
- •Enrollment in active clinical trial/ experimental therapy within the last 30 days
- •Currently on another dietary treatment approach
结局指标
主要结局
Inflammatory blood markers
时间窗: 3 months
To evaluate the cytokines levels (IL-I b; IL-6; IL-8; IL-10; IL-12; IL-17; TNF-a) of participants with irritable bowel syndrome from baseline levels to 12 weeks by using a Bio-Plex 200 System (Bio-Rad, California, USA).
次要结局
- Gastrointestinal symptoms severity(3 months)
- The quality of life(3 months)