Vitamin D Regulation of Gut Specific B Cells and Antibodies Targeting Gut Bacteria in Inflammatory Bowel Disease

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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 .

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Doris Duke Charitable Foundation
• Treatments: Vitamin D

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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