- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Taipei, Taiwan
- Taipei Medical University Hospital.
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
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.
Andere Namen:
|
|
Placebo-Komparator: 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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
SARS-CoV-2 spike protein-specific IgG antibody level
Zeitfenster: 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.
|
Baseline (Day 0-7 before vaccination), Day 14 (±4 days), and Day 28 (±4 days) after first dose of BNT162b2 vaccination
|
|
SARS-CoV-2-specific T cell immune response at Day 14 after vaccination.
Zeitfenster: 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.
|
Baseline and Day 14 (±4 days) after vaccination
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Infektionen der Atemwege
- Infektionen
- RNA-Virusinfektionen
- Viruserkrankungen
- Erkrankungen der Atemwege
- Lungenkrankheit
- Pneumonie, viral
- Lungenentzündung
- Coronavirus-Infektionen
- Coronaviridae-Infektionen
- Nidovirales-Infektionen
- COVID-19
- Nahrungsergänzungsmittel
- Essen
- Ernährung, Nahrung und Ernährung
- Physiologische Phänomene
- Essen und Getränke
- Probiotika
- Lacteol
Andere Studien-ID-Nummern
- N202109037
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .