Exploring how gut bacteria and diet affect flu vaccine response
Delineating Gut Microbiome and Dietary Determinants Associated With Favorable Vaccine Response
M.D. Anderson Cancer Center · NCT05239403
This study is trying to see how the bacteria in our gut and what we eat affect how well the flu vaccine works for people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05239403 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between gut microbiome diversity, dietary factors, and the immune response to the influenza vaccine. Participants will complete questionnaires and provide blood and stool samples to assess their gut microbiome and immune response before and after vaccination. The study aims to identify specific microbial signatures and dietary patterns that correlate with vaccine efficacy, potentially leading to strategies for enhancing vaccine responses. Additionally, it will explore connections between these findings and responses to cancer immunotherapy.
Who should consider this trial
Good fit: Ideal candidates are MD Anderson employees aged 18 or older who are receiving the seasonal influenza vaccine.
Not a fit: Patients with contraindications to the influenza vaccine will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized dietary recommendations to improve vaccine efficacy in patients.
How similar studies have performed: While the association between gut microbiome and vaccine response is an emerging field, similar studies have shown promising results, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. MD Anderson employees and student employees with existing MRN 2. Must be able to donate blood 3. Participants must be age 18 or older 4. Participants must receive the seasonal influenza vaccine at MD Anderson through Employee Health 5. Participants must consent to gut microbiome profiling, REDCap-based dietary screening questionnaire (Appendix A) and survey (Appendix B), and vaccine immune response testing which requires one stool sample, and two blood draws Exclusion Criteria: 1. Participants with a contraindication to the recommended annual influenza vaccine Pregnant women may be included in this study.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Jennifer Wargo — M.D. Anderson Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Influenza