Clinical Trial

Effect of Oral Supplements for Influenza Vaccine Response

Study acronym: EOSIIVE-RCT
Not Yet Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated February 14, 2025 (before its estimated May 2025 completion). Its status may not reflect the trial's current state.
Summary
The aim of this clinical trial is to explore the efficacy of fatty acid and bile acid based supplements on enhancing influenza vaccine immune response in adults aged 60-70 years. The objectives of this study are: 1. To explore the efficacy of fatty acid and bile acid based supplements on enhancing flu vaccine immune response. 2. To evaluate the safety of fatty acid and bile acid use in elders. 3. To explore the potential role of microbiota in regulating immune response. This study will conduct a randomized clinical trial to compare the efficacy of fatty acid / bile acid (Tauro Ursodesoxy Cholic Acid, TUDCA)supplements on enhancing vaccine immune response. The antibody's titer and safety indicators after influenza vaccination will be evaluated. Study process are: 1. Participants will be required to intake the assigned supplement or placebo daily for 25 days; 2. Receive a influenza vaccine on day 4; 3. Provide blood samples three times and stool samples twice at base line and endpoint respectively; 4. The antibody's titer and safety indicators will be analyzed and compared among groups. This study aims to establish a theoretical foundation for utilizing nutritional strategies to enhance vaccine-induced immune responses and to provide a scientific framework for developing oral vaccine boosters.
Trial Details
NCT Number NCT06827873
Lead Sponsor Tsinghua University
Collaborators: Second Affiliated Hospital of Bengbu Medical College
Conditions Influenza Vaccine Response
Enrollment 45 participants
Start Date 2025-02
Primary Completion 2025-05 (estimated)
Study Completion 2025-10 (estimated)
Updated on ClinicalTrials.gov 2025-02-14