Inflammatory Bowel DiseasesNCT05584735
Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine
An observational study of Inflammatory Bowel Diseases, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will evaluate the effect of the microorganisms in the gut on how well the flu or COVID-19 vaccine works in people who have a weakened immune system due to inflammatory bowel disease. Participants can expect to be in the study for up to 65 days. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Influenza vaccine and COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2023to 20 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants diagnosed with IBD
Who may be able to join
- 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:
- Group A: Anti-TNF Therapy Group
- Maintenance monotherapy: infliximab (at least 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 on anti-TNF therapy as described above along with either methotrexate, azathioprine, or 6MP
- Group B: Non-TNG biologic
Show all 14Show fewer
- Ustekinumab Therapy: on either ustekinumab monotherapy or combination therapy with methotrexate, azathioprine, or 6MP
- Vedolizumab Therapy: on either vedolizumab monotherapy or combination therapy with methotrexate, azathioprine, or 6MP
- Risankizumab Therapy: 360mg at least every 8 weeks
- Group C: Janus Kinase Therapy
- Tofacitinib Therapy: at least 5mg PO BID
- Upadactinib Therapy: at least 15mg PO daily
- Patient has been on stable treatment for IBD for at least three months
- Must be able to provide research samples between 28-65 days post influenza or Covid-19 vaccination.
Who cannot join
- Member of a vulnerable group (pregnant, lacking consent capacity, non-English speaking)
- Recent oral antibiotics within previous 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine in Immunosuppressed Patients With Inflammatory Bowel Disease
This study will evaluate the effect of the microorganisms in the gut on how well the flu or COVID-19 vaccine works in people who have a weakened immune system due to inflammatory bowel disease. Participants can expect to be in the study for up to 65 days.
Read the detailed description
The overall objective of this study is to evaluate the role of gut microbiome in influenza or COVID-19 vaccine response in immunosuppressed populations. Microbial diversity (alpha diversity) is decreased in immunosuppressed patients and might be associated with lower immunogenicity to vaccines.
It is known that patients with IBD have dysbiosis of their gut microbiome and those immunosuppressed may have a lower vaccine response. In this aim, the investigators will evaluate whether differences in microbial diversity predict immune response to the influenza and COVID-19 vaccine.
In this prospective study, immunosuppressed IBD patients will be vaccinated per standard of care and blood will be collected to measure the immune response. A fecal and saliva sample will be collected to characterize the gut microbiome. The investigators hypothesize that reduced richness / alpha-diversity in gut microbiota will correlate with those with a blunted vaccine response.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Influenza vaccine, COVID-19 vaccine
- Keywords
- Crohn's disease, ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccineBiological
Observe effects of flu vaccine on microbiome
COVID-19 vaccineBiological
Observe effects of COVID-19 vaccine on microbiome
| Study group | Role | What they receive |
|---|---|---|
| Participants with Inflammatory Bowel Disease (IBD) | Participants with IBD who are receiving a flu or COVID-19 vaccine Receives: Biological: Influenza vaccine; Biological: COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza or COVID-17 antibody concentrations
Hemagglutination inhibition assay (HIA) will be used to measure influenza antibodies in blood. COVID-19 antibody concentration analysis will be completed with LabCorp's Cov2Quant IgG™ assay which uses immunoassay that uses electrochemiluminescent technology (ECL) for quantitative determination of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2.
Measured: Baseline
Influenza or COVID-19 antibody concentrations
Hemagglutination inhibition assay (HIA) will be used to measure influenza antibodies in blood. COVID-19 antibody concentration analysis will be completed with LabCorp's Cov2Quant IgG™ assay which uses immunoassay that uses electrochemiluminescent technology (ECL) for quantitative determination of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2.
Measured: One blood draw between 28-65 days after baseline
Microbiome metrics
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.
Measured: One stool collection between days 0-65
Microbiome stability
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.
Measured: One stool collection between days 0-65
Secondary outcomes (2)
Correlation between Fecal Metabolomic Activity and Vaccine Response
Measured: up to 65 days
Correlation between Saliva DNA and Vaccine Response
Measured: up to 65 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start3 Nov 2023
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Freddy Caldera, DO, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584735
- Sponsor's protocol ID
- 2021-0977
- Other IDs
- A534250, SMPH/MEDICINE/GASTROENT, Protocol version 7/18/2024
- Status last verified
- Jul 2025
- First submitted
- 14 Oct 2022
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine in Immunosuppressed Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05584735
- Acronym / sponsor ID
- 2021-0977
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Crohn's disease, ulcerative colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of the microorganisms in the gut on how well the flu or COVID-19 vaccine works in people who have a weakened immune system due to inflammatory bowel disease. Participants can expect to be in the study for up to 65 days.
Detailed description
The overall objective of this study is to evaluate the role of gut microbiome in influenza or COVID-19 vaccine response in immunosuppressed populations. Microbial diversity (alpha diversity) is decreased in immunosuppressed patients and might be associated with lower immunogenicity to vaccines.
It is known that patients with IBD have dysbiosis of their gut microbiome and those immunosuppressed may have a lower vaccine response. In this aim, the investigators will evaluate whether differences in microbial diversity predict immune response to the influenza and COVID-19 vaccine.
In this prospective study, immunosuppressed IBD patients will be vaccinated per standard of care and blood will be collected to measure the immune response. A fecal and saliva sample will be collected to characterize the gut microbiome. The investigators hypothesize that reduced richness / alpha-diversity in gut microbiota will correlate with those with a blunted vaccine response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Inflammatory Bowel Disease (IBD) | – | Biological: Influenza vaccine, Biological: COVID-19 vaccineParticipants with IBD who are receiving a flu or COVID-19 vaccine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants diagnosed with IBD
Key inclusion criteria (14 listed)
- 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:
- Patient has been on stable treatment for IBD for at least three months
- Must be able to provide research samples between 28-65 days post influenza or Covid-19 vaccination.
Key exclusion criteria (2 listed)
- Member of a vulnerable group (pregnant, lacking consent capacity, non-English speaking)
- Recent oral antibiotics within previous 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccineObserve effects of flu vaccine on microbiome | Biological | Participants with Inflammatory Bowel Disease (IBD) |
| COVID-19 vaccineObserve effects of COVID-19 vaccine on microbiome | Biological | Participants with Inflammatory Bowel Disease (IBD) |
Primary outcome
Influenza or COVID-17 antibody concentrations
Time frame: Baseline
Hemagglutination inhibition assay (HIA) will be used to measure influenza antibodies in blood. COVID-19 antibody concentration analysis will be completed with LabCorp's Cov2Quant IgG™ assay which uses immunoassay that uses electrochemiluminescent technology (ECL) for quantitative determination of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2.
Influenza or COVID-19 antibody concentrations
Time frame: One blood draw between 28-65 days after baseline
Hemagglutination inhibition assay (HIA) will be used to measure influenza antibodies in blood. COVID-19 antibody concentration analysis will be completed with LabCorp's Cov2Quant IgG™ assay which uses immunoassay that uses electrochemiluminescent technology (ECL) for quantitative determination of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2.
Microbiome metrics
Time frame: One stool collection between days 0-65
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
Time frame: One stool collection between days 0-65
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.
2 secondary outcomes
Correlation between Fecal Metabolomic Activity and Vaccine Response
Time frame: up to 65 days
Correlation between Saliva DNA and Vaccine Response
Time frame: up to 65 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freddy Caldera, DO, MS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza or COVID-17 antibody concentrations (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025; AzTrials last refreshed its copy on 1 Nov 2026.