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

September 19, 2023 updated by: John Gubatan, Stanford University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D 50,000 IU PO every week
Vitamin D 50,000 IU PO every week for 12 weeks
Drug: Vitamin D
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Week 12
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
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Week 12
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
Week 12
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
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Doris Duke Charitable Foundation

Investigators

  • Principal Investigator: John Mark Gubatan, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-60958

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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