Patients with IBD are randomized to oral administration of VitaminB6 and placebo based on the standard treatment, exploring whether VitaminB6 can increasee the clinical remission rateand improve the treatment effect of IBD patients.
Inflammatory bowel disease (IBD) is a group of chronic idiopathic inflammatory intestinal diseases, mainly including ulcerative colitis and Crohn's disease, with increasing incidence in China and worldwide. The disease currently lacks a cure, with many patients experiencing relapses and requiring surgery, and an increased risk of cancer. There is substantial evidence suggesting a close relationship between body vitamin B6 levels and IBD.Thus,we design this clinical trial that aims to explore whether VitaminB6 can increasee the clinical remission rateand improve the treatment effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
The experimental group was given a Vitamin B6 tablet(10mg/tablet)once a day for 3weeks, besides of the standard IBD treatment.
The control group was given a placebo tablet on the same type once a day for 3weeks, besides of the standard IBD treatment.
Changhai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGClinical remission rate
To evaluate the improvement effect of clinical remission rate (Mayo score ≤ 2 points and no single sub-score\>1 point; CDAl score\<150) in IBD patients after 3 weeks of oral Vitamin B6 while taking routine treatment.
Time frame: Through study completion, an average of 6 months .
Disease activity score of IBD patients
Modified Mayo score or CDAl score
Time frame: Through study completion, an average of 6 months .
Histological remission
Based on the Geboes scale. No or slight increase of chronic inflammatory infiltration in lamina propria, no neutrophils in lamina propria or epithelium, no persistent clinicai response of erosion, ulcer or granulation tissue.
Time frame: Through study completion, an average of 6 months .
Clinical response
Modified Mayo score decreased by 2 points and 30% from baseline+rectal bleeding score decreased by 1 point or absolute rectal bleeding score decreased by 1 point.
Time frame: Through study completion, an average of 6 months .
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