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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Taipei, 대만
- Taipei Medical University Hospital.
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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SARS-CoV-2 spike protein-specific IgG antibody level
기간: 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.
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- N202109037
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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