Dietary Control of Fat to Modify Colonic Inflammation in Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ).
研究概览
简要总结
The primary purpose of this study is to determine the effectiveness of a low-fat or standard American diet (high in fat) in helping people with ulcerative colitis improve their symptoms and the signs of inflammation in blood tests and in bowel biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female ≥18 and ≤70 years old
- •History of UC of at least 3 months duration
- •UC should be confirmed by colonoscopy within two years of entry into the study
- •Patients with mild to moderate UC, or patients in remission that have had active disease within the past 18 months, regardless of treatment with mesalamines, immunosuppressants, anti-TNFs and/or vedolizumab
- •Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥2 weeks prior to screening
- •Patients treated with anti-TNFs or immunosuppressants (AZA, 6-MP, or methotrexate) at screening must have been on a stable dose for ≥8 weeks and remain on the same dose during the treatment period
- •Patients on steroids can be on no more than prednisone 20mg daily or budesonide 9mg daily at screening. If clinically indicated, tapering of steroids after 4 weeks of intervention may occur. Prednisone may be tapered by no more than 2.5mg/week and budesonide by no more than 3mg/week.
- •Patients on infliximab, premedication may include intravenous corticosteroid
- •No antibiotic use or probiotic use within 4 weeks prior to screening
- •Signed written informed consent for enrollment into the study
排除标准
- •Patients with Crohn's Disease and Celiac Disease
- •History of colonic dysplasia except for adenoma on prior surveillance colonoscopy
- •Patients with altered anatomy: prior colectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
- •Clinical manifestations concerning for fulminant disease or toxic megacolon
- •Patients with stool sample positive at during screening period or at least <12 weeks for ova, parasites, or culture for aerobic pathogens including: Aeromonas, Plesiomonas, Shigella, Yersinia, Campylobacter and E.coli spp. or positive for Clostridium difficile B toxin in stools
- •Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening
- •Need for prednisone >20mg daily or budesonide >9mg daily at the time of screening
- •Received intravenous corticosteroids within 2 weeks prior to screening, during screening, or during the study period, except as premedication for anti-TNFs
- •Use of Total Parenteral Nutrition at the time of screening and during the study period
- •Anti-diarrheal use within 2 weeks prior to screening
- •Presence of any of the following laboratory abnormalities during screening period or at least <12 weeks
- •Hemoglobin <8.0g/dl
- •Albumin <2.8g/dl
- •Conditions/situations such as:
- •Patients with short life expectancy
- •Uncooperative behavior or any condition that could make the patient potentially non-compliant to the study procedures
- •Patients with pacemaker
- •Other significant or life-threatening co-morbidities in which diet intervention could negatively affect
- •Failure to meet any of the inclusion criteria
- •Poor compliance with diet during the study period
- •Failure to submit stool samples as indicated at each phase of the study
- •The need for antibiotic use during the study period
研究组 & 干预措施
Low Fat Diet (LFD) to Standard American Diet (SAD)
Week 1 to 4 participants will receive a LFD followed by a washout period of 2 weeks and then week 6 to 10 SAD.
干预措施: LFD (Other)
Low Fat Diet (LFD) to Standard American Diet (SAD)
Week 1 to 4 participants will receive a LFD followed by a washout period of 2 weeks and then week 6 to 10 SAD.
干预措施: SAD (Other)
SAD to LFD
Week 1 to 4 participants will receive a SAD followed by a washout period of 2 weeks and then week 6 to 10 LFD.
干预措施: LFD (Other)
SAD to LFD
Week 1 to 4 participants will receive a SAD followed by a washout period of 2 weeks and then week 6 to 10 LFD.
干预措施: SAD (Other)
结局指标
主要结局
Change in quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ).
时间窗: Baseline, 4 weeks
sIBDQ is a 10-item shortened version of the original IBDQ assessing quality of life (QOL) with total scores ranging from 1 to 7 with a higher score indicating a better QOL.
Change in quality of life as measured by the Food-Related Quality of Life (FR-QoL-29) Questionnaire.
时间窗: Baseline, 4 weeks
FR-QoL-29 is a 29-item questionnaire assessing quality of life (QOL) with total scores ranging from 29 to 145 with a score less than 90 suggesting poor food related QoL.
Change in the expression of inflammatory markers in the colon.
时间窗: Baseline, 4 weeks
Change in the expression of interleukin (IL)-1β, IL-6 and Tumor Necrosis Factor alpha (TNFa) evaluated in pg/mL.
Change in quality of life as measured by the Medical Outcomes Short Form-36 (SF-36) Questionnaire.
时间窗: Baseline, 4 weeks
SF-36 is a 36-item questionnaire assessing quality of life (QOL) with total scores ranging from 0 to 100 with a higher score indicating a better QOL.
Change in the expression of cytokine in the colon.
时间窗: Baseline, 4 weeks
Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluted in mg/L.
Change in intestinal microbiota
时间窗: Baseline, 4 weeks
Change in relative abundance of the microbial communities evaluated as a percentage.
次要结局
- Rate of adherence to fat intake(Baseline, 4 weeks)
- Change in Ulcerative Colitis (UC) symptoms as measured by the partial Mayo score(Baseline, 4 weeks)
- Change in UC symptoms as measured by the Simple Clinical Colitis Activity Index (SCCAI)(Baseline, 4 weeks)
- Rate of adherence to diet items(Baseline, 4 weeks)
研究者
Maria Abreu
Professor of Medicine
University of Miami