A Study to Evaluate Non-invasive Measurements of the Inflammatory Status in Patients with IBD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Correlation of the the PPG signal with any dynamic biomarker
研究概览
简要总结
Patients with IBD, including both Crohn's disease and ulcerative colitis, require accurate monitoring of intestinal inflammation for optimal follow-up and treatment. Traditional markers like C-reactive protein (CRP) and faecal calprotectin are useful but are either invasive or disliked by patients and a proper continuous monitoring is not feasible with fragmented biomarker information.
The NimBio technology provides support for the clinicians who are managing IBD patients' care based on a wearable technology that allows tracking responsiveness of blood flow properties (also called hemorheology) to inflammatory processes. NimBio's technology analyses blood flow properties using photoplethysmography (PPG), an optical signal, which detects blood flow changes in the microvascular bed of tissues. The PPG signal is obtained from a commercially available wearable (bracelet) which is convenient for the patients. Based on the impact of inflammation on parameters influencing hemorheology (mainly blood vessel stiffness, blood viscosity and red blood cell aggregation) and the fact that the PPG signal mirrors blood flow characteristics, PPG measurements are associated with changes in inflammatory biomarkers and therefore correlate with disease activity.
This offers a possibility for continuous, non-invasive monitoring of inflammation. The study aims to further validate the NimBio Inflammometer and its value for monitoring inflammatory changes and dynamics in patients with IBD at the University Hospitals Leuven.
详细描述
Patients with IBD, including both Crohn's disease and ulcerative colitis, require accurate monitoring of intestinal inflammation for optimal follow-up and treatment. Traditional markers like C-reactive protein (CRP) and faecal calprotectin are useful but are either invasive or disliked by patients and a proper continuous monitoring is not feasible with fragmented biomarker information.
The NimBio technology provides support for the clinicians who are managing IBD patients' care based on a wearable technology that allows tracking responsiveness of blood flow properties (also called hemorheology) to inflammatory processes. NimBio's technology analyses blood flow properties using photoplethysmography (PPG), an optical signal, which detects blood flow changes in the microvascular bed of tissues. The PPG signal is obtained from a commercially available wearable (bracelet) which is convenient for the patients. Based on the impact of inflammation on parameters influencing hemorheology (mainly blood vessel stiffness, blood viscosity and red blood cell aggregation) and the fact that the PPG signal mirrors blood flow characteristics, PPG measurements are associated with changes in inflammatory biomarkers and therefore correlate with disease activity.
This offers a possibility for continuous, non-invasive monitoring of inflammation. The study aims to further validate the NimBio Inflammometer and its value for monitoring inflammatory changes and dynamics in patients with IBD at the University Hospitals Leuven
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- •Diagnosis of IBD (Crohn's disease or ulcerative colitis) or IBDU
- •Hospitalized or ambulatory patients with active IBD defined as:
- •HBI ≥ 5, or PMS score ≥3, and
- •Faecal Calprotectin ≥200 μg/g or CRP > 10 mg/ml, and
- •Access to iOS or Android-based smartphone with internet access
- •Ambulatory patients would be recruited to the study with a gender ratio that will not deviate from a 40:60 ratio in favor of either gender
排除标准
- •Allergy to steel or elastomer/rubber
- •Using a pacemaker, implantable cardiac defibrillator, neurostimulator, or other electronic medical equipment
研究组 & 干预措施
IBD patients with inflammometer
blood samples, stool samples, questionnaires and inflammometer measurements
干预措施: Inflammometer (Device)
结局指标
主要结局
Correlation of the the PPG signal with any dynamic biomarker
时间窗: 6 months
Correlation of the inflammatory dynamics (trajectory) as measured by NimBio's technology with any dynamic biomarker in the IBD patient population
次要结局
- Correlation of the PPG signal with the patient inflammatory status(6 months)
- Classification of the inflammatory status based on the PPG signal(6 months)
- Correlation of the inflammatory trajectory with the patient's inflammatory status(6 months)
- Classification of the inflammatory status compared to the clinical disease activity(6 months)
- Time of NimBio's indication of a change in the inflammatory status(6 months)
- Assessment of physiological parameters(6 months)
- Assessment of patient satisfaction(6 months)
- Assessment of the correlation between the inflammatory status and disease activity(6 months)
- The effect of the integration of physiological parameters into NimBio's algorithm(6 months)
研究者
Marc Ferrante
Prof. dr. Marc Ferrante
Universitaire Ziekenhuizen KU Leuven