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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental:VitaminB6 group | Experimental | Based on the standard treatment,VitaminB6 (10mg/tablet)is given orally once a day,one tablet each time,for 3 weeks. |
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| Placebo Comparator:Control group | Placebo Comparator | Based on the standard treatment,the same type of placebo tablets are given orally once a day,one tablet each time,for 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B6 Tablets | Drug | The experimental group was given a Vitamin B6 tablet(10mg/tablet)once a day for 3weeks, besides of the standard IBD treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical 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. | Through study completion, an average of 6 months . |
| Measure | Description | Time Frame |
|---|---|---|
| Disease activity score of IBD patients | Modified Mayo score or CDAl score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaoshen Li | Contact | +86-21-25070552 | zhaoshenlismmu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaoshen Li | The First Affiliated Hospital of Naval Medical University | Principal Investigator |
| Shu Zhu | The University of Science and Technology of China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D025101 | Vitamin B 6 |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Double-blind randomized controlled trial involving patients and healthcare providers
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| Placebo | Drug | The control group was given a placebo tablet on the same type once a day for 3weeks, besides of the standard IBD treatment. |
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| 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. | Through study completion, an average of 6 months . |