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COMPLETEDPHASE1

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

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

NCT04828031•Stanford University

View on ClinicalTrials.gov

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 .

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Key Dates

Start Date

July 1, 2021

Primary Completion Date

July 1, 2023

Completion Date

July 1, 2023

Last Updated

September 21, 2023

Enrollment

ACTUAL participants

Conditions

Inflammatory Bowel DiseasesUlcerative ColitisCrohn Disease

Interventions

Vitamin D

DRUG

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

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Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITING

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

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RECRUITINGPHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)