Clinical Study of Vitamin B5 in Adjuvant Treatment of IBD

Study Overview
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Brief Summary
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Patients with IBD are randomized to oral administration of vitamin B5 and placebo based on the standard treatment, exploring whether Vitamin B5 can increase the clinical remission rate of IBD patients and improve the treatment effect.

Official Title
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Clinical Study of Vitamin B5 in Adjuvant Treatment of Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Drug: Vitamin B5 Tablets
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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: Hemophilic patients; There are abdominal abscesses, toxic megacolon, fulminant colitis, partial colectomy, or total colectomy; Other autoimmune diseases, hematological diseases, tumors, acute infection, severe liver and kidney insufficiency, serious diseases such as severe anemia, neutropenia, heart failure, organic heart disease, hepatitis B, liver cirrhosis, kidney disease and mental diseases; Take calcium pantothenate preparation in recent 3 months; Have a history of abuse of psychoactive substances; Pregnant or lactating women, or plan to be pregnant in the next 6 months; Nervous system diseases: such as Alzheimer's disease, stroke, Parkinson's disease; Participate in other clinical trials in the past 6 months; Incomplete medical record information (including gender, age, diagnosis information, colonoscopy results, pathological diagnosis results and other demographic data)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin B5 group<br>Based on the standard IBD treatment, Vitamin B5 (5mg/tablet) is given orally three times a day, four tablets each time, for 12 weeks. | Drug: Vitamin B5 Tablets<br>* The experimental group was given Vitamin tablets (5mg/tablet) based on the standard IBD treatment.<br>|
| Placebo Comparator: Control group<br>Based on the standard IBD treatment, the same type of placebo tablets are given orally three times a day, four tablets each time, for 12 weeks. | Drug: placebo<br>* The control group was given placebo tablets of the same type based on the standard IBD treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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; CDAI score<150) in IBD patients after 12 weeks of oral Vitamin B5 while taking routine treatment. | Through study completion, an average of 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity score of IBD patients | Modified Mayo score or CDAI score | Through study completion, an average of 12 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 clinical response of erosion, ulcer or granulation tissue. | Through study completion, an average of 12 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 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin B5,treatment