Vitamin B6 Aids in Treating Inflammatory Bowel Disease
- Conditions
- Inflammatory Bowel Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT06512441
- Lead Sponsor
- Changhai Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 220
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental：VitaminB6 group Placebo Based on the standard treatment，VitaminB6 （10mg/tablet）is given orally once a day,one tablet each time,for 3 weeks. Placebo Comparator:Control group Vitamin B6 Tablets Based on the standard treatment，the same type of placebo tablets are given orally once a day,one tablet each time,for 3 weeks. Experimental：VitaminB6 group Vitamin B6 Tablets Based on the standard treatment，VitaminB6 （10mg/tablet）is given orally once a day,one tablet each time,for 3 weeks. Placebo Comparator:Control group Placebo Based on the standard treatment，the same type of placebo tablets are given orally once a day,one tablet each time,for 3 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Disease activity score of IBD patients Through study completion, an average of 6 months . Modified Mayo score or CDAl score
Trial Locations
- Locations (1)
Changhai Hospital
🇨🇳Shanghai, Shanghai, China