CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
1 week placebo(Week 1) +5 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05195047
NCT05195047N/ACompleted
CompareCT.gov

Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination: A Prospective, Randomized, Double-blind, Placebo-Controlled Trial (Trial 2)

Peking University·interventional·Posted Jan 18, 2022·Updated Nov 3, 2022

In Brief

A clinical study evaluating 1 week placebo(Week 1), 1 week of probiotics(Week 1), and 4 other interventions for SARS-CoV-2. Completed, enrolled 44 participants across 2 sites.

Detailed Summary

Preliminarily explore the effect of oral probiotics in SARS-CoV-2 serum neutralizing antibody titer level and T cell response level (spot formation cell counting). Provide a reference for determining the appropriate oral regimen. Provide necessary parameters for estimating the sample size of confirmatory clinical trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2
CountriesChina
CollaboratorsCenters for Disease Control and Prevention, China, Beijing Pinggu District Hospital, Peking University Health Science Center Hospital

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 18, 2022
Enrollment StartFeb 27, 2022
Primary CompletionAug 21, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.5 years ago

Interventions

1 week placebo(Week 1)dietary

1 week of consecutively consuming oral placebo (1 time/day)

1 week of probiotics(Week 1)dietary

1 week of consecutively consuming oral probiotics (1 time/day)

1 week placebo(Week 2)dietary

1 week of consecutively consuming oral placebo (1 time/day)

1 week of probiotics(Week 2)dietary

1 week of consecutively consuming oral probiotics (1 time/day)

1 week placebo(Week 3)dietary

1 week of consecutively consuming oral placebo (1 time/day)

1 week of probiotics(Week 3)dietary

1 week of consecutively consuming oral probiotics (1 time/day)