Clinical trial NCT06512441: Vitamin B6 Aids in Treating Inflammatory Bowel Disease
Official title: Vitamin B6 Assists in the Treatment of Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: VitaminB6
treatment
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical remission rate
timeFrame: Through study completion, an average of 6 months .
Secondary outcomes:
measure: Disease activity score of IBD patients
timeFrame: Through study completion, an average of 6 months .
measure: Histological remission
timeFrame: Through study completion, an average of 6 months .
measure: Clinical response
timeFrame: Through study completion, an average of 6 months .
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: The First Affiliated Hospital of Naval Medical University
name: Zhaoshen Li
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Science and Technology of China
name: Shu Zhu
role: STUDY_DIRECTOR
References: