Inflammatory Bowel Diseases
Conditions
Keywords
VitaminB6, treatment
Brief summary
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.
Detailed description
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.
Interventions
DRUGVitamin B6 Tablets
The experimental group was given a Vitamin B6 tablet（10mg/tablet）once a day for 3weeks, besides of the standard IBD treatment.
DRUGPlacebo
The control group was given a placebo tablet on the same type once a day for 3weeks, besides of the standard IBD treatment.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind randomized controlled trial involving patients and healthcare providers
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with IBD according to the consensus on the diagnosis and treatment of inflammatory bowel disease (Beijing, 2018, DOI: 10.19538/j.nk2018090106); * Have complete medical history data; * Volunteer to participate in this clinical trial and sign the informed consent form.
Exclusion criteria
* Patients with peripheral neuropathy; * Patients with abdominal abscess, toxic megacolon, fulminant colitis, partial colectomy, or total colectomy; * Patients with other autoimmune diseases, hematologic disorders, tumors, acute infections, severe liver or kidney dysfunction, severe conditions such as severe anemia, neutropenia, heart failure, organic heart disease, hepatitis B, cirrhosis, kidney disease, and psychiatric disorders; * Patients who have taken vitamin B6 tablets in the past 3 months; * Patients with a history of substance abuse; * Pregnant or lactating women, or those planning to become pregnant within the next 6 months; * Neurological disorders such as Alzheimer's disease, stroke, Parkinson's disease; * Participation in other clinical trials in the past 6 months; * Incomplete medical records (including gender, age, diagnosis, colonoscopy results, pathological diagnosis results, and other demographic data); * Currently taking: levodopa, phenobarbital, phenytoin sodium.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity score of IBD patients | Through study completion, an average of 6 months . | Modified Mayo score or CDAl score |
| Histological remission | 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. |
| Clinical response | 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. |
Countries
China
Contacts
Primary ContactZhaoshen Li
Outcome results
None listed