Pro-active Fecal Calprotectin Monitoring to Improve Patient Outcomes in Ulcerative Colitis: A Prospective Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 726
- 试验地点
- 2
- 主要终点
- The time to a symptomatic flare, defined as an increase in modified partial Mayo score > 2 points from baseline or a rectal bleeding score > 1
研究概览
简要总结
Hypothesis:
Pro-active home fecal calprotectin testing in patients with Ulcerative Colitis will allow early detection and treatment of inflammation to prevent symptomatic flares. This will result in less steroid use, fewer hospitalizations and a reduced risk of surgery, as well as improved quality of life and adherence to medication.
详细描述
Previous studies have shown that fecal calprotectin (FC) may be useful to predict relapse of inflammatory bowel disease and response to treatment. Current methods for measurement of FC require bringing stool samples to the laboratory or physician's office. The test is either not readily available or is expensive for patients. Some patients also find it inconvenient to collect, transport and travel to return the sample.
A prior study in our institution showed that only 77% of patients returned samples for processing. Therefore, a home-based kit may offer greater uptake by patients as samples do not need to be returned to a lab or physician's office. Regular monitoring of patients at home may allow the detection and prediction of flares before the appearance of symptoms. With earlier treatment, the risk of complications may be minimized and the quality of life for people living with this disease may be improved.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 19 years or older with Ulcerative Colitis
- •Symptomatic remission defined as a modified Partial Mayo score ≤ 2 with a rectal bleeding score = 0
- •Able to use IBDocTM test kit which requires a smart phone with a camera and internet access to download the CalApp® which interprets the measurement
- •Able to give informed consent to the study protocol
排除标准
- •Patients experiencing a symptomatic flare
- •Patients currently receiving therapy as part of a clinical trial
- •Pregnancy
研究组 & 干预措施
Control
The group will receive current standard of care as the usual practice of the attending physician. Basic research data will be collected and participants in this group will be asked to complete the on-line questionnaires (SIBDQ and EQ-5D 5L) on the baseline visit and month 6, 12 and month 18.
When endoscopy is performed biopsies should be taken and the endoscopic and histologic assessment will be recorded. If a fecal calprotectin is measured, every effort should be made to use the IBDoc with the result being sent to the central primary investigator via the IBDoc Web Portal. However, should a different fecal calprotectin measure be used, this will be recorded as part of the study documentation and will be included in the study data.
Intervention: FC measurements with IBDoc
Fecal Calprotectin (FC) measurements with IBDocTM home kits will be performed by participants in the intervention group every 2 months until final visit.
Basic research data will be collected and participants in this group will be asked to complete the on-line questionnaires (SIBDQ and EQ-5D 5L) on baseline visit and month 6, 12 and month 18.
干预措施: Fecal Calprotectin (FC) measurements with IBDocTM (Other)
结局指标
主要结局
The time to a symptomatic flare, defined as an increase in modified partial Mayo score > 2 points from baseline or a rectal bleeding score > 1
时间窗: 6 months
All patients in both control and intervention group will be contacted every 6 months until end of study. Partial Mayo and rectal bleeding score will be obtained and if there is an increase in partial Mayo score \> 2 points from baseline or a rectal bleeding score \> 1, this is considered as flare. Endoscopy will be performed wherever possible.
次要结局
- Proportion of subjects who underwent an escalation of therapy(6 months)
- Quality of life measured by SIBDQ questionnaire(6 months)
- Hospitalization, surgery, steroid or biologic use(6 months)
- Correlation of fecal calprotectin with endoscopic activity(6 months)
- Quality of life measured by EQ-5D 5L questionnaire(6 months)
- Time lost from work or school(6 months)
- Correlation of fecal calprotectin with histologic disease activity(6 months)
- Number of physician visits(6 months)
- Successful use of IBDoc(2 months)
研究者
Greg Rosenfeld
Clinical Assistant Professor
University of British Columbia