The Impact of Time Restricted Feeding in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Inflammatory Markers as measured by blood C-reactive protein (CRP).
研究概览
简要总结
Time-restricted feeding (TRF) is a dietary regimen involving the consumption of food and liquids within a defined time window with or without additional restriction on dietary composition. TRF has been associated with improvements in inflammation, host metabolism, autophagy, gut microbial composition, and gut permeability. Crohn's disease is an inflammatory bowel disease of unknown etiology that likely results from a combination of genetic and environmental factors. This proposed study will test the hypothesis that a time-restricted feeding regimen will improve clinical outcomes and favorably influence the gut microbiome in patients with active Crohn's disease. If time-restricted fasting proves beneficial to this patient population then it will pave the way for larger, prospective studies and clinical trials.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects has active Crohn's disease of the ileum and/or colon. The diagnosis should be confirmed by endoscopic or radiological evidence.
- •Active inflammation on colonoscopy performed as evidenced by an SES-CD ≥ 6 (or ≥ 4 for isolated ileal disease) OR C-Reactive protein ≥ 1.0 mg/L OR fecal calprotectin ≥ 250 μg/g. Any or all of these results must be from within 180 days of study entrance.
- •Subject should have BMI of >18.5 and <40
排除标准
- •Subjects who decline to provide informed consent
- •Subject with a history of an eating disorder, major gastrointestinal surgery within the past 3 months.
- •Subject with a history of antibiotic use within 4 weeks.
- •Subject with a history of bowel obstruction within the past 12 months
- •Subject with a history of diabetes requiring medication
- •Subject who is currently pregnant or breastfeeding will be excluded
- •Subjects with current antibiotic use. In order to participate, subjects will be required to have a 2-week wash-out period.
结局指标
主要结局
Change in Inflammatory Markers as measured by blood C-reactive protein (CRP).
时间窗: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
This will be measured to assess clinical response as determined by a reduction of 50% or more from baseline or normalization of the CRP level results.
Change in inflammatory markers as measured by fecal calprotectin lab results
时间窗: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
This will be measured to assess clinical changes as determined by a reduction of 50% or more from baseline or normalization of the calprotectin levels results.
Change in patient reported outcomes as measured by Patient Recorded Outcome 2 (PRO2) scores.
时间窗: Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet
This will be measured to assess clinical response as determined by a reduction of either 8 or more points or a total PRO2 score of less than or equal to 8 points. The PRO2 score scale ranges from a score of 0 as the minimum and has no maximum limit. A score below 8 is considered remission; a score less than 14 is considered mild; and a score greater than 34 is considered severe.
次要结局
- Markers of systemic peripheral blood immunity as measured by Mass Cytometry by Time-Of-Flight (CyTOF) analysis.(Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet)
- Change in taxonomic composition of the gut microbiome as measured by Polymerase Chain Reaction (PCR) analysis.(Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet)