Changhai Hospital
Shanghai, Shanghai Municipality, China
Location status: Recruiting
NCT Number: NCT06512441
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The experimental group was given a Vitamin B6 tablet(10mg/tablet)once a day for 3weeks, besides of the standard IBD treatment.
Other names: Treatment
The control group was given a placebo tablet on the same type once a day for 3weeks, besides of the standard IBD treatment.
Other names: Control
Time frame: Through study completion, an average of 6 months .
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 .
Modified Mayo score or CDAl score
Time frame: Through study completion, an average of 6 months .
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 .
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.
Contact information is provided by the study sponsor or research team.
Changhai Hospital
Other
Vitamin B6 Assists in the Treatment of Inflammatory Bowel Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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