NCT05180279已完成不适用
The Impact of Circadian Misalignment on Colonic Barrier Homeostasis in Ulcerative Colitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in Dim Light Melatonin Onset (DLMO) From Baseline (Aligned) to Circadian Misalignment Misalignment
研究概览
简要总结
The purpose of this study is to investigate if circadian malalignment (unusual sleeping patterns), such as night shifts (sleeping during the day and being awake during the night time), worsens the inflammation of the gut. We hope to look at patients with Ulcerative Colitis and Healthy Controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •UC patients:
- •M/F, 18-50 y/o
- •Inactive Disease (Mayo Score ≤ 2)
- •Stable medications with no disease flares for the > 3 months
- •Left-sided UC (Montreal E1 or E2)
- •Normal psychological evaluation and negative drug screen (See Below)
- •Healthy Controls:
- •M/F, 18-50 y/o, age ± 3y sex, race, and BMI match with UC subject
- •No clinical evidence of any medical illness
- •Normal psychological evaluation and negative drug screen (See Below)
排除标准
- •UC patients:
- •Patients with other forms of colitis such as Crohn's disease (CD) or indeterminate colitis
- •Patient with active UC (Mayo > 2)
- •Pancolonic UC (colitis past the splenic flexure, Montreal E3))
- •Use of biologic or immunomodulatory medications (i.e. Infliximab, Adalimumab, azathioprine, Vedolizumab, methotrexate, etc.)
- •Gastrointestinal surgery
- •Other GI diseases or systemic diseases (cardiac, renal failure, cirrhosis)
- •Shift work in the last 6 months
- •Antibiotic use within last 12 weeks
- •Patients who have used anti-diarrheal agents such as Lomotil or Imodium within 3 days of the study
- •Prednisone use the last 30 days
- •Significant Depression (score ≥ 14 BDI)
- •Significant Anxiety (score ≥ 40 STAI)
- •Use of probiotic supplement in last 4 weeks except yogurt.
- •Intentional change in diet.
- •Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study. Low dose aspirin is allowed.
- •Chronic Alcohol use. A washout period of 3 weeks is needed before the subject could be enrolled into the study.
- •Have children under 6 months
- •Healthy Controls:
- •History of drug abuse, gastrointestinal (GI) surgery, GI diseases, or systemic diseases such as renal (creatinine>1.2 mg/dl), liver, cardiac, or diabetes (Hgb-A1c>8%)
- •Antibiotic use within last 12 weeks
- •Shift work in the last 6 months
- •Use of probiotic supplement except yogurt in last 4 weeks.
- •Atypical American diet with daily fiber ≥ 16 grams or daily saturated fat ≤ 11 grams by Food Frequency Questionnaire
- •Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study.
- •Chronic Alcohol use. A washout period of 3 weeks is needed before the subject could be enrolled into the study.
- •Significant Depression (score ≥ 14 BDI)
- •Significant Anxiety (score ≥ 40 STAI)
- •Regular use of medications that affect intestinal permeability, intestinal motility and/or endogenous melatonin including metoclopramide, NSAIDs, antibiotics, beta blocker, psychotropic medication, hypnotics and exogenous melatonin products during 4 weeks prior to the study
- •People who crossed more than 2 time zones in the previous month
- •Inability to sign an informed consent form.
- •Have children under 6 months
结局指标
主要结局
Change in Dim Light Melatonin Onset (DLMO) From Baseline (Aligned) to Circadian Misalignment Misalignment
时间窗: Blood is drawn every hour over 8 hours to measure plasma melatonin in dim light < 5 lux in Aligned Circadian Rhythms, and blood is drawn every hour for 12 hours under dim light in Misaligned Circadian rhythms.
Amount of time between dim light melatonin onset (DLMO) to sleep onset. The hours reported for this outcome measure equates the time of the day the participant fell asleep
Change in Intestinal Permeability From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment
时间窗: 24 hour urine collection beginning at baseline and 24 hour urine collection at circadian misalignment, an average of 3 days from baseline to circadian misalignment
Intestinal permeability is assessed through spectrophotometric measurements of sucralose, sucrose, maltose and lactulose concentrations in urine following ingestion of a sugar cocktail.
次要结局
- Change in 24 Hour Urinary Melatonin Concentrations From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment(24 hour urine collection at baseline and 24 hour urine collection at circadian misalignment circadian)
- Change in Stool Calprotectin From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment(10 minute stool collection conducted at baseline circadian rhythm and at circadian misalignment.)
- Change in Concentration of Serum Cytokine Markers of Inflammation From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment(Blood is drawn every two hours over a 24 hour period at baseline (12 draws), and blood is drawn every two hours over a 24 hour period at circadian misalignment)
- Change in Mayo Score From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment(30 minute flexible sigmoidoscopy at Baseline and 30 minute flexible sigmoidoscopy at Circadian Misalignment)
- Changes in Clock Gene Expression in Peripheral Blood Mononuclear Cells From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment(Blood is drawn every two hours over a 24 hour period at baseline (12 draws), and blood is drawn every two hours over a 24 hour period at circadian misalignment)
- Changes in Gene Expression of Colonic Tissue Biopsies From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment(30 minute flexible sigmoidoscopy at Baseline and 30 minute flexible sigmoidoscopy at Circadian Misalignment)
研究者
Ali Keshavarzian
Principal Investigator
Rush University Medical Center
研究点 (2)
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