A Prospective Study to Determine the Immunomodulatory Effect of Probiotics on the Immunogenicity of Anti-SARS-CoV-2 Vaccine Recipients Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- SARS-CoV-2 spike protein-specific IgG antibody level
研究概览
简要总结
This study aims to evaluate whether oral probiotic supplementation can modulate the immune response induced by COVID-19 vaccination. Specifically, the study will assess the effects of probiotics on vaccine-induced antibody responses and cellular immune responses, and explore whether probiotics may enhance or accelerate immunity and reduce vaccine-related adverse effects. A total of 140 participants are planned to be enrolled.
详细描述
Large-scale clinical trials have demonstrated that COVID-19 vaccines effectively reduce the incidence of COVID-19, as well as the risk of severe disease and mortality. These protective effects are primarily mediated through vaccine-induced immune responses, including both humoral immunity (antibody production) and cellular immunity.
Probiotics are widely recognized for their potential health benefits and are commonly consumed in foods such as yogurt. Emerging evidence suggests that probiotic supplementation may enhance immune responses to vaccination, as demonstrated in studies involving influenza vaccines.
This study is designed to investigate whether oral probiotic supplementation can modulate the immune response to COVID-19 vaccination. The study will evaluate both antibody responses and cellular immune responses following vaccination, and assess whether probiotics can enhance or accelerate the development of vaccine-induced immunity. In addition, the study will explore whether probiotic supplementation may reduce vaccine-related adverse effects.
A total of 140 participants are planned to be enrolled in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
This is a single-blind (participant-blinded) study. Participants will be randomized to receive either probiotic capsules or matching placebo capsules. The placebo capsules contain microcrystalline cellulose and are identical in appearance, packaging, and administration schedule to the probiotic capsules. Participants will be blinded to treatment assignment, while investigators and study staff will not be blinded.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subject ≥ 20 to ≤ 65 years of age at the time signing informed consent form.
- •Body weight ≥50 kgs
- •Must be scheduling to receive a BNT162b2 mRNA COVID-19 vaccine
- •Being able to comply with the study protocol
- •Being able to independently provide written informed consent
排除标准
- •Taking antibiotic at enrollment
- •Taking immunomodulatory (e.g., steroid) or anti-histamine drugs
- •Took pre- or probiotics within the past 30 days
- •Being to expected to take other probiotic supplement during the study period
- •Being expected to take antibiotic during the study period
- •A history of hypersensitivity or severe allergic reaction to any components of the probiotics or placebo supplement
- •Pregnant or breastfeeding
- •Having a severe immunocompromised disorder (e.g. HIV infection)
- •Solid organ or bone marrow transplant recipients
- •Major gastrointestinal surgery within 3 months before enrollment
- •Having severe active gastrointestinal conditions, including inflammatory bowel disease or diverticulitis
- •No self-reported symptoms of an upper airway infection with the past 2 weeks
- •A history of SARS-CoV-2 infection
- •Previously participated in investigational study involving SARS-CoV-2 vaccines or therapies
研究组 & 干预措施
Probiotic Group
Participants will receive oral probiotic capsules containing Lactobacillus spp. once daily for 4-5 weeks following COVID-19 vaccination. The intervention is administered to evaluate the immunomodulatory effects of probiotics on vaccine-induced humoral and cellular immune responses.
干预措施: Probiotics (Dietary Supplement)
Placebo Group
Participants will receive matching placebo capsules containing microcrystalline cellulose once daily for 4-5 weeks following COVID-19 vaccination. The placebo is identical in appearance, packaging, and administration schedule to the probiotic capsules.
干预措施: Placebo (Other)
结局指标
主要结局
SARS-CoV-2 spike protein-specific IgG antibody level
时间窗: Baseline (Day 0-7 before vaccination), Day 14 (±4 days), and Day 28 (±4 days) after first dose of BNT162b2 vaccination
Change in SARS-CoV-2 spike protein-specific IgG antibody levels following COVID-19 vaccination between probiotic and placebo groups.
SARS-CoV-2-specific T cell immune response at Day 14 after vaccination.
时间窗: Baseline and Day 14 (±4 days) after vaccination
Assessment of vaccine-induced cellular immune response measured by antigen-specific T cell activation between probiotic and placebo groups.
次要结局
未报告次要终点