A Pilot Study Investigating a Decentralized Approach to Studying Dietary Intervention in Patients With Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score)
研究概览
简要总结
This study is designed to assess differences in remote and on-site patient study participation in the State of Massachusetts, as well as the significance of dietary interventions and their impact on UC. The study will activate one site with a Principal Investigator who will utilize each subject's local care system (local Gastroenterologist) to collect study data, along with telemonitoring and video visits, to make key study assessments and decisions regarding subjects' progression in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between the ages of 18 and 80, inclusive, who reside in the state of Massachusetts.
- •Ability and willingness to provide documented informed consent and to comply with the study procedures, including in-person visits for Arm 1 and video visits for Arm
- •Documented history of moderate to severe active UC
- •Disease duration of ≥12 weeks at the time of screening (diagnosed according to American College of Gastroenterology practice guidelines)
- •Screening fecal calprotectin>350 mg/g
- •Diagnosis of moderately to severely active UC, including historical endoscopy sub score ≥2; a rectal bleeding sub score ≥1 and disease activity a minimum of 25 cm from the anal verge.
- •Documented (via video or report) endoscopy performed within 2 years prior to randomization.
- •Access to a computer or mobile device with internet connection and an active email address.
排除标准
- •Prior extensive colonic resection, subtotal or total colectomy or planned surgery for UC
- •Past or present ileostomy or colostomy
- •Short bowel syndrome
- •Diagnosis of indeterminate colitis, fulminant colitis, toxic megacolon
- •Past or present fistula or abdominal abscess
- •History or current evidence of colonic mucosal dysplasia
- •Use of tube feeding, defined formula diets or parenteral alimentation/nutrition which has not been discontinued ≥3 weeks prior to study enrollment
- •Use of anticoagulants, herbal supplements and omega-3/fish oil supplements during the study
- •Crohn's Disease
- •Significant uncontrolled co-morbidity, such as neurological, cardiac (e.g., moderate to severe heart failure NYHA class III/IV), pulmonary, renal, hepatic, endocrine or gastrointestinal disorders
- •History of alcohol, drug or chemical abuse within 6 months prior to screening
- •Pregnant females, those intending to become pregnant, and those who are lactating
- •Current participation in any other clinical trial
结局指标
主要结局
Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score)
时间窗: Week 1
Comparison of the proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score between Study Arms 1 and 2.
Compliance (proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study)
时间窗: Week 7
Comparison of the proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study between Study Arms 1 and 2.
Combined Anti-inflammatory Diet (Change from baseline in fecal calprotectin/microbiome levels)
时间窗: Weeks 0, 5 and 7
Change from baseline in fecal calprotectin/microbiome levels between Control (standard nutritional advice) and CAID (dietary intervention) arms.
次要结局
- Mayo Score and Patient Simple Clinical Colitis Activity Index Difference (Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index)(Weeks 1 and 7)
- Adverse Events(Weekly through week 11)
- Dietary Compliance Comparison(Week 7)
- Participant Satisfaction Survey(Week 7)
- Mayo Score Discrepancy Frequency(Week 7)
- Physician's Global Assessment Discrepancy Frequency(Week 7)