The Clinical and Microbial Impact of Prebiotics in Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Microbial composition
研究概览
简要总结
The cause of inflammatory bowel disease (IBD) is currently unknown, although partly attributed to interactions among genetic risk polymorphisms, environmental factors, gut microbiome, and host immunity. Diet, particularly those with plant-based products, have been shown in prior research to improve gut microbial composition, which has been linked to different IBD-related outcomes. This study is interested in evaluating the impact of prebiotics on gut microbiome composition and gut health in patients with IBD.
Dietary composition will be assessed at baseline and over the course of 16 weeks. Participants will be randomized to either consume an 8-week course of prebiotic supplementation beginning at week 0 or week 8. Stool samples will be collected at weeks 0 and 8. The stool will be analyzed for cross-sectional and longitudinal fecal microbial changes associated with different prebiotic and diet consumption patterns in the context of heterogeneous disease characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigator and outcomes assessor will not be aware of participants' assignments.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 to 85 years old
- •History of biopsy-proven ulcerative colitis (UC)
- •Active symptoms (SCCAI >2)
- •Concomitant use of 5-aminosalicylates, immunomodulators, and corticosteroids will be permitted, although initiation or dose adjustment must not have occurred within 30 days prior to enrollment.
- •Concomitant use of biologic therapy will be permitted, although initiation or dose adjustment must not have occurred within 60 days prior to enrollment.
- •Prior probiotics or other dietary supplements use is permitted but will be asked to be discontinued during the course of the trial
排除标准
- •Prior colectomy
- •Hospitalization
- •Urgent need for abdominal surgery
- •Unstable major medical condition
- •Active malignancy under treatment
- •Active alcohol or non-cannabinoid substance abuse
- •Pregnancy or lactation
- •Concerns for non-compliance
结局指标
主要结局
Microbial composition
时间窗: Week 8
Microbial composition includes a measurement and characterization of the relative quantity of genera and species.
Clinical response
时间窗: Week 8
Clinical response will be defined as a reduction of Simple Colitis Clinical Activity Index (SCCAI). Range of SCCAI is 0-20 (higher is more severe).
次要结局
- Microbial composition(Week 16)
- Clinical response(Week 16)
- Clinical remission(Week 16)
研究者
Berkeley Limketkai, MD, PhD
Associate Clinical Professor
University of California, Los Angeles