Immunomodulatory Effect of Probiotics on the Immunogenicity of Anti-SARS-CoV-2 Vaccines
A Prospective Study to Determine the Immunomodulatory Effect of Probiotics on the Immunogenicity of Anti-SARS-CoV-2 Vaccine Recipients Study.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Taipei、台湾
- Taipei Medical University Hospital.
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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Oral probiotic capsules containing Lactobacillus spp.
administered once daily for 4-5 weeks following COVID-19 vaccination to evaluate immunomodulatory effects on vaccine-induced immune responses.
他の名前：
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プラセボコンパレーター：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.
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Matching placebo capsules containing microcrystalline cellulose administered once daily for 4-5 weeks following COVID-19 vaccination.
The placebo is identical in appearance, packaging, and schedule to the probiotic capsules.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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SARS-CoV-2 spike protein-specific IgG antibody level
時間枠：Baseline (Day 0-7 before vaccination), Day 14 (±4 days), and Day 28 (±4 days) after first dose of BNT162b2 vaccination
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Change in SARS-CoV-2 spike protein-specific IgG antibody levels following COVID-19 vaccination between probiotic and placebo groups.
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Baseline (Day 0-7 before vaccination), Day 14 (±4 days), and Day 28 (±4 days) after first dose of BNT162b2 vaccination
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SARS-CoV-2-specific T cell immune response at Day 14 after vaccination.
時間枠：Baseline and Day 14 (±4 days) after vaccination
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Assessment of vaccine-induced cellular immune response measured by antigen-specific T cell activation between probiotic and placebo groups.
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Baseline and Day 14 (±4 days) after vaccination
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- N202109037
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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