Vitamin D Regulation of α4β7+ B Cell Immunophenotypes and Mucosal Antibody Response to Commensal Gut Bacteria in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Reduction in α4β7+ B cells by 20%
研究概览
简要总结
Specific Aim 1: Characterize the effects of vitamin D treatment on expression of α4β7 on B cells in patients with inflammatory bowel disease (IBD).
Specific Aim 2: Determine the effects of vitamin D treatment on fecal immunoglobulins, percentage of Ig-coated gut bacteria, gut microbiome composition (global and bound by immunoglobulins) in patients with IBD and the association of these parameters with change in α4β7+ B cells .
Specific Aim 3: Compare BCR repertoire (BCR clonotypes, immunoglobulin heavy chain gene (IGHV), and isotype usage) between α4β7+ and α4β7- B cells in patients with IBD and identify α4β7+ BCR clonotypes associated with Ig-bound gut bacteria .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 years or older) with inflammatory bowel disease (ulcerative colitis or Crohn's disease)
- •Low serum vitamin D (25(OH)D ≤ 25 ng/mL
- •Not currently on high dose vitamin D supplementation
- •No prior bowel resections
- •No antibiotic use in past 3 months.
排除标准
- •Patients less than 18 years old
- •No diagnosis of IBD
- •Serum 25(OH)D > 25 ng/mL
- •Patients already on vitamin D supplementation
- •Prior history of bowel surgery (colectomy or small bowel resections)
- •Recent antibiotic use in past 3 months
- •Renal Dysfunction
- •History of Hypercalcemia
- •History of HIV
- •History of IgA deficiency
- •History of Common Variable Immunodeficiency (CVID)
- •Active C. diff infection
研究组 & 干预措施
Vitamin D 50,000 IU PO every week
Vitamin D 50,000 IU PO every week for 12 weeks
干预措施: Vitamin D (Drug)
结局指标
主要结局
Reduction in α4β7+ B cells by 20%
时间窗: Week 12
Expression of gut tropic integrin α4β7+ on B cells assessed at gene expression level (single cell transcriptomics) and protein level (cytometry)
Reduction in immunoglobulin coating of commensal gut bacteria by 20%.
时间窗: Week 12
Immunoglobulin coating of gut bacteria will be measured from stool samples using Ig-Seq
次要结局
- Decrease in disease activity index scores by 50%(Week 12)
- Increase in serum vitamin D (25(OH)D levels by 10 ng/mL(Week 12)
- Decrease cohort mean fecal calprotectin or C-reactive protein (CRP) by 50%.(Week 12)
研究者
John Gubatan
Fellow in Gastroenterology
Stanford University