This is a prospective, multicenter, observational cohort study, which plans to enroll patients with active IBD who are scheduled to initiate IFX or VDZ treatment between October 2025 and October 2027 at Xijing Hospital, Tang-du Hospital, and Air Force 986 Hospital. All patients will undergo HRV monitoring at baseline, Week 2, Week 6, and Week 14. The HRV monitoring results will be blinded to both physicians and patients. Based on the efficacy assessment at Week 14, patients will be divided into response and non-response groups for comparison, to analyze the strength of association between baseline HRV parameters and the achievement of clinical response. The study plans to enroll 100 IBD patients, with 50 in the IFX treatment group and 50 in the VDZ treatment group.
Study Type
OBSERVATIONAL
Enrollment
100
Xijing Hospital
Xi'an, Shaanxi, China
Disease activity
The SCCAI score was used to assess clinical disease activity in patients with ulcerative colitis (UC). Clinical response was defined as a reduction in the SCCAI score of ≥3 points from baseline; clinical remission was defined as an SCCAI score ≤2 points. The HBI score was used to assess clinical disease activity in patients with Crohn's disease (CD). Clinical response was defined as a reduction in the HBI score of ≥3 points from baseline; clinical remission was defined as an HBI score ≤4 points.
Time frame: At baseline, Week 2, Week 6, and Week 14.
Heart Rate Variability
A patch-type dynamic electrocardiogram recorder is used to detect HRV. This product is suitable for collecting, monitoring, and storing three-lead dynamic electrocardiogram signals in adults and can be worn continuously. HRV parameters are obtained through continuous 72-hour dynamic ECG data acquisition.
Time frame: At baseline, Week 2, Week 6, and Week 14.
Sleep Monitoring
Smart wearable sleep tracking devices (Huawei Band 10) are used for complementary sleep monitoring. Key parameters to be measured include total sleep time, wake after sleep onset and sleep architecture.
Time frame: During 14 weeks of treatment.
Pittsburgh Sleep Quality Index (PSQI)
PSQI is used to evaluate the sleep quality of the subjects in the last 1 month. There are 7 dimensions and 9 entries with a total score between 0 and 21, where a score higher than 5 indicates a sleep quality problem, 0 to 5 indicates good sleep quality, 6 to 10 indicates moderate sleep quality, 11 to 15 indicates poor sleep quality, and 16 to 21 indicates very poor sleep quality.
Time frame: At baseline, Week 6, and Week 14.
Insomnia Severity Index (ISI)
The ISI is used to evaluate the severity of insomnia in patients, primarily evaluating sleep problems over the past two weeks and their impact on quality of life. The scale consists of seven items, each rated on a 5-point scale (0 = none, 4 = very severe), with a total score ranging from 0 to 28. Higher scores indicate more severe insomnia, where 0-7 points indicate no clinically significant insomnia, 8-14 points indicate subthreshold insomnia, 15-21 points indicate moderate clinical insomnia, and 22-28 points indicate severe clinical insomnia.
Time frame: At baseline, Week 6, and Week 14.
Flinders Fatigue Scale (FFS)
The FFS is a brief self-rated questionnaire specifically designed to assess daytime fatigue associated with insomnia, commonly used for rapid screening of patients' fatigue levels. The scale comprises 7 items, primarily measuring fatigue characteristics over the past two weeks. The first six items are scored from 0 (not at all) to 4 (extremely severe), while the time period item is scored based on the number of time periods checked (1 point per time period). All item scores are summed to obtain the total score, which typically ranges from 0 to 31, with higher scores indicating greater severity of fatigue.
Time frame: At baseline, Week 6, and Week 14.
Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is used to evaluate the symptoms and severity of anxiety in patients. It includes 7 entries, each with a score of 0 to 3 and a total score between 0 and 21. Higher scores indicate greater anxiety severity. The commonly used classification criteria are as follows: 0-4 points (no or minimal anxiety), 5-9 points (mild anxiety), 10-14 points (moderate anxiety), and 15-21 points (severe anxiety). A total score of 10 or higher is generally indicated the possible presence of an anxiety disorder.
Time frame: At baseline, Week 6, and Week 14.
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is used to assess the symptoms and severity of depression in patients. It consists of nine main entries, each with a score of 0 to 3 and a total score between 0 and 27. The score is generally used to determine the severity of depression: 0-4 points indicate no depression, 5-9 points indicate mild depression, 10-14 points indicate moderate depression, 15-19 points indicate moderately severe depression, and 20 or higher points indicate severe depression.
Time frame: At baseline, Week 6, and Week 14.
Therapeutic drug monitoring
All patients will undergo measurement of drug trough concentrations for IFX and VDZ at Week 14 of treatment. The concentration testing will be performed within 24 hours prior to the next scheduled infusion (i.e., close to the time of drug administration).
Time frame: Week 14.
Fecal calprotectin (FC)
FC is a widely used biomarker in the assessment and management of iIBD. As a stable protein released by activated neutrophils during intestinal inflammation, FC can effectively reflect the degree of mucosal inflammation non-invasively; elevated FC levels correlate with active intestinal inflammation, helping to distinguish between inflammatory bowel disease and functional gastrointestinal disorders such as irritable bowel syndrome. It also plays an important role in monitoring disease activity, evaluating treatment response, detecting early mucosal recurrence, and supporting clinical decision-making in patients with IBD.
Time frame: At baseline and Week 14.
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