By conducting a randomized controlled study of the role of enteral nutrition biscuits in the induction of remission in moderate-to-severe Crohn's disease, we will evaluate to investigate the role of enteral nutrition biscuits in the induction and remission phases of moderate-to-severe Crohn's disease; to assess patient adherence to enteral nutrition biscuits and the timing of their application; to assess the role of enteral nutrition biscuits in biologically refractory patients; and to assess the role of enteral nutrition biscuits in the remission of perianal, small bowel, and colonic lesions.
This project is a randomized controlled study evaluating the effects of enteral nutrition biscuits during the induction and remission phases of moderate to severe Crohn's disease. The study subjects were patients with moderate to severe Crohn's disease, and the control group received conventional treatment with existing drugs; The experimental group added oral enteral nutrition biscuits to intervene on the basis of existing drugs. Evaluate the clinical response rates of patients at 2, 4, 8, 12, and 24 weeks after intervention; Nutritional status before and after intervention, incidence and severity of perianal lesions, and remission rate of small intestine and colon lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Addition of enteral nutritional biscuits to existing pharmacological treatment.
Crohn's disease activity index, CDAI
Assessment was performed using the Crohn's disease activity index (CDAI), with a clinical response defined as a CDAI score \<150.
Time frame: 2、4、8、12、24 weeks after intervention
Induced remission success rate
Probability of success of intervention in inducing CD remission.
Time frame: 2、4、8、12、24 weeks after intervention
Gastrointestinal Symptom Rating Scale (GSRS) score
Gastrointestinal Symptom Rating Scale (GSRS) score.
Time frame: 2、4、8、12、24 weeks after intervention
Gastrointestinal symptom remission
Gastrointestinal Symptom Rating Scale (GSRS) scores after 4 weeks of intervention.
Time frame: 4 weeks after intervention
Detection of antibody levels to the biologics used in sera from patients with secondary loss of response to the biologics
Detection of antibody levels to the biologics used in sera from patients with secondary loss of response to the biologics.
Time frame: 1、4、8、12、24 weeks after intervention
Incidence and severity of perianal lesions in both groups
Assess the incidence and severity of perianal lesions in both groups.
Time frame: 1、8、24 weeks after intervention
Rate of endoscopic remission of small bowel and colon lesions in both groups
Assess the rate of endoscopic remission of small bowel and colon lesions in both groups.
Time frame: 1、8、24 weeks after intervention
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Changes in inflammatory biomarkers (C-reactive protein, fecal calreticulin) in both groups
Assess the changes in inflammatory biomarkers (C-reactive protein, fecal calreticulin) in both groups.
Time frame: 1、4、8、12、24 weeks after intervention
Adverse events and serious adverse events, safety and tolerability, with treatment-related adverse events and number of occurrences as assessed by CTCAE v5.0
Adverse events and serious adverse events, safety and tolerability, with treatment-related adverse events and number of occurrences as assessed by CTCAE v5.0.
Time frame: 1、4、8、12、24 weeks after intervention