UC Cohort - The Influence of Diet on Host Physiology and Disease Across Diverse Human Gut Microbiotas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Clinical remission derived from patient reported outcomes
研究概览
简要总结
The purpose of this research is to determine if different diets have different effects on the inflammation in the colon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Adults ≥ 18 years old
- •Ability to give informed consent
- •Diagnosis of ulcerative colitis
- •Moderate UC disease activity defined by a Mayo Score of >6 with endoscopic score of 2
- •On a baseline diet characterized by:
- •Fiber intake of < 15g/day
- •> 18% of daily calories from protein
排除标准
- •Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
- •Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
- •Use of NSAIDs or aspirin and unable or unwilling to stop taking two weeks prior to permeability test and for the duration of the study
- •Use of osmotic laxatives and unable or unwilling to stop taking one week prior to permeability test and for the duration of the study
- •Use of oral corticosteroids and unable or unwilling to stop use of oral corticosteroids within the previous 2 weeks and for the duration of the study
- •Multiple dietary restrictions or unable/unwilling to alter dietary protein or dietary fiber.
- •Unwilling to stop ingestion of alcohol and artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages
- •Unwilling to stop stenuous exercise (running >5 miles or equivalent) one week prior to the permeability tests
- •Bowel preparation for colonoscopy less than one week prior to completion of the first stool kit and permeability test and flexible sigmoidoscopy and upper endoscopy
- •Pregnancy or plan to become pregnant during the study time frame
- •Vulnerable adult
- •Known bleeding disorders or takes medications that increase risk of bleeding from mucosal biopsies
- •Use of oral antibiotic(s) within the past 4 weeks (can be enrolled after 4-week washout period)
- •Use of commercial probiotic formulations and unwilling to stop for the duration of the study
- •Diagnosis of diabetes
- •Any other disease(s), condition(s) or habits(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes
研究组 & 干预措施
High Protein and Low Fiber Group
Subjects will consume a high protein and low fiber diet for 8 weeks
干预措施: High Protein and Low Fiber Diet (Dietary Supplement)
Low Protein and High Fiber Group
Subjects will consume a low protein and high fiber diet for 8 weeks
干预措施: Low Protein and High Fiber Diet (Dietary Supplement)
结局指标
主要结局
Clinical remission derived from patient reported outcomes
时间窗: 8 weeks
Defined as a Mayo score ≤2 and no sub-scores with a value greater than 1 is a secondary endpoint. This what the patient reports for stool frequency and reporting of any blood in the stool
Decrease in endoscopic Mayo score for ulcerative colitis inflammation
时间窗: 8 weeks
Measured from unprepped, non-sedated flexible sigmoidoscopy by decrease in Mayo score with a decrease of at least 1 point on the endoscopic subscore or absolute endoscopic subscore of 0-1).
次要结局
- Urinary excretion of lactulose and 13C-Mannitol(8 weeks)
- Intestinal inflammation determined from blood and stool samples(8 weeks)
研究者
Laura E. Raffals, M.D
Principal Investigator
Mayo Clinic