Trial Search Results

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

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 .

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Doris Duke Charitable Foundation

Stanford Investigator(s):

Intervention(s):

  • Drug: Vitamin D

Phase:

Phase 1

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
John Gubatan, MD
650-725-3362
Recruiting