- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07610512
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Taipei, Taiwan
- Taipei Medical University Hospital.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
Altri nomi:
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Comparatore placebo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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SARS-CoV-2 spike protein-specific IgG antibody level
Lasso di tempo: 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.
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Infezioni delle vie respiratorie
- Infezioni
- Infezioni da virus a RNA
- Malattie virali
- Malattie delle vie respiratorie
- Malattie polmonari
- Polmonite, virale
- Polmonite
- Infezioni da coronavirus
- Infezioni da Coronaviridae
- Infezioni da Nidovirus
- COVID-19
- Integratori dietetici
- Cibo
- Dieta, cibo e nutrizione
- Fenomeni fisiologici
- Cibo e bevande
- Probiotici
- Lattelo
Altri numeri di identificazione dello studio
- N202109037
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .