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Completed

NCT Number: NCT04828031

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 .

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Dysbiosis Gastroenteritis Gastrointestinal Diseases Inflammation Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

Patient with inflammatory bowel disease who have low vitamin D (25(OH)D less than or equal to 25 ng/mL) will take Vitamin D 50,000 IU by mouth every week for 12 weeks. Patients will fill out questionnaires to document disease activity score (HBI or Mayo score and sIBDQ) and have blood and stool samples collected before (Week 0), during (Week 8) and after (Week 12) vitamin D intervention.

Primary outcomes

  1. Reduction in α4β7+ B cells by 20%

    Time frame: Week 12

    Expression of gut tropic integrin α4β7+ on B cells assessed at gene expression level (single cell transcriptomics) and protein level (cytometry)

  2. Reduction in immunoglobulin coating of commensal gut bacteria by 20%.

    Time frame: Week 12

    Immunoglobulin coating of gut bacteria will be measured from stool samples using Ig-Seq

Secondary outcomes

  1. Increase in serum vitamin D (25(OH)D levels by 10 ng/mL

    Time frame: Week 12

    25(OH)D will be measured from serum by standard laboratory assay (HPLC)

  2. Decrease in disease activity index scores by 50%

    Time frame: Week 12

    Disease activity index scores will be measured by Harvey Bradshaw Index in Crohn's disease patients and Mayo Score disease activity index in ulcerative colitis patients

  3. Decrease cohort mean fecal calprotectin or C-reactive protein (CRP) by 50%.

    Time frame: Week 12

    Fecal calprotectin will be measured from stool samples. CRP will be measured from plasma

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Doris Duke Charitable Foundation

Registry information

Official study title

Vitamin D Regulation of α4β7+ B Cell Immunophenotypes and Mucosal Antibody Response to Commensal Gut Bacteria in Patients With Inflammatory Bowel Disease

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2021
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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