Determining the Relationship Between Gut Microbiota and Immune Response to Influenza Vaccine

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05584735

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study will evaluate the effect of the microorganisms in the gut on how well the flu vaccine works in people who have a weakened immune system due to inflammatory bowel disease. Participants can expect to be in the study for 1 month.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Biological: Influenza vaccine

Detailed Description

The overall objective of this study is to evaluate the role of gut microbiome in influenza vaccine response in immunosuppressed populations. Microbial diversity (alpha diversity) is decreased in immunosuppressed patients and might be associated with lower immunogenicity to influenza vaccine.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Determining the Relationship Between Gut Microbiota and Immune Response to Influenza Vaccine in Immunosuppressed Patients With Inflammatory Bowel Disease

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Participants with Inflammatory Bowel Disease (IBD) Participants with IBD who are receiving a flu vaccine	Biological: Influenza vaccine Observe effects of flu vaccine on microbiome

Arm

Intervention/Treatment

Participants with Inflammatory Bowel Disease (IBD)

Participants with IBD who are receiving a flu vaccine

Biological: Influenza vaccine

Observe effects of flu vaccine on microbiome

Outcome Measures

Primary Outcome Measures

Influenza antibody concentrations [Baseline]
Hemagglutination inhibition assay (HIA) will be used to measure influenza antibodies in blood.
Influenza antibody concentrations [One blood draw between 14-28 days after baseline]
Hemagglutination inhibition assay (HIA) will be used to measure influenza antibodies in blood.
Microbiome metrics [One stool collection between days 0-28]
Microbiome metrics will include phylogenetic diversity, and analyses of relative abundance of microbes using 16SrRNA gene sequence data from fecal material. Alpha diversity of the microbiome will be evaluated.
Microbiome stability [One stool collection between days 0-28]
Microbiome stability will be evaluated using hierarchical clustering of weighted and unweighted UniFrac distances (a beta diversity metric indexing compositional similarity/difference) for microbiome using 16SrRNA gene sequence data from fecal material.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic, and histopathologic criteria
Currently one of the following groups:

Maintenance monotherapy: infliximab (at least 8 every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)
Combination Therapy: Anti-TNF Combination Therapy Group (approximately 40- 50% of the group): on anti-TNF therapy as described above along with either 15mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg.
Group C: Ustekinumab on either ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.
Group D: Vedolizumab Therapy Group: Vedolizumab Therapy: on either vedolizumab monotherapy or combination therapy with methotrexate or azathioprine

Stable treatment for IBD for at least three months

Exclusion Criteria:

Received season's influenza vaccine
Member of a vulnerable group (pregnant, lacking consent capacity, non-English speaking)
Recent antibiotics within previous 2 months

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator: Freddy Caldera, DO, MS, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT05584735

Other Study ID Numbers:

2021-0977
A534250
SMPH/MEDICINE/GASTROENT
Protocol version 7/7/2021

First Posted:

Oct 18, 2022

Last Update Posted:

Oct 24, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of Wisconsin, Madison

Crohn's disease

ulcerative colitis

Additional relevant MeSH terms:

Intestinal Diseases

Inflammatory Bowel Diseases

Study Results

No Results Posted as of Oct 24, 2022