A Phase 4 interventional study of Receive recombinant B-subunit/whole-cell cholera vaccine and Placebo in Bowel Habits, Gut Microbiomes and Inflamatory Markers, sponsored by Zhejiang Provincial Center for Disease Control and Prevention. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Zhejiang Provincial Center for Disease Control and Prevention · Phase 4, Interventional, and Other
This randomized, placebo-controlled clinical trial aims to investigate the effects of oral cholera vaccine administration on three aspects of gut health in healthy adult community members aged 18 years and older: (1) the composition and function of gut microbiota, (2) serum inflammatory cytokine levels, and (3) bowel habits. The study is designed as an exploratory/basic science investigation to generate hypotheses about how cholera vaccination may influence intestinal health in healthy populations. The findings from this study may provide valuable insights into vaccine-induced changes in the gut microbiome and immune responses, which could inform future research on oral vaccines and their extra-intestinal effects.
Participants who agree to take part in this study will be asked to complete the following procedures at two time points: before receiving the study intervention (baseline) and 28 days after completing the full vaccine series.
Approximately 200 healthy adults aged 18 years and older from the community will be enrolled in this study. Participants will be randomly assigned in a 1:1 ratio to one of two study groups: Intervention Group (Vaccine Group): receive the oral cholera vaccine according to the manufacturer's recommended schedule; Control Group (Placebo Group): receive a placebo that looks identical to the vaccine but contains no active ingredient.
The study will measure the following outcomes to evaluate the effects of cholera vaccine:Gut Microbiota Changes, Serum Inflammatory Cytokine Levels and Bowel Habit Changes.
Zhejiang Provincial Center for Disease Control and Prevention is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Administration of placebo
Other: Placebo
Receive recombinant B-subunit/whole-cell cholera vaccine
Drug: Receive recombinant B-subunit/whole-cell cholera vaccine
Participants in this group will receive the oral cholera vaccine according to the manufacturer's recommended schedule (3 dose, at 0d, 7d, 28d).
Participants in this group will receive a placebo that looks identical to the vaccine but contains no active ingredient (3 dose, at 0d, 7d, 28d).
Change in gut microbiota alpha diversity (Shannon and Chao1 indices), beta diversity (Bray-Curtis dissimilarity), and microbial composition assessed by 16S rRNA gene sequencing of stool samples
Stool specimens will be collected and subjected to high-throughput sequencing of the 16S rRNA gene. Alpha diversity will be quantified using the Shannon index and Chao1 index, reflecting within-sample microbial richness and evenness. Beta diversity will be assessed using Bray-Curtis dissimilarity to characterize between-group differences in microbial community structure. Microbial composition will be summarized as the relative abundance of taxa at the phylum, family, genus, and, where possible, species levels. Outcome data will be reported as mean or median alpha diversity indices by group or time point, between-group or within-subject differences in diversity indices, relative abundance of major taxa, and beta diversity distances among samples.
Time frame: Before vaccine/placebo received and 28 days after 3 dose vaccine/placebo received
Bowel habits
A questionnaire survey will be conducted on bowel habits over the past month (stool consistency, defecation frequency, and defecation time).
Time frame: Before vaccine/placebo received and 28 days after 3 dose vaccine/placebo received
Plasma levels of inflammatory markers, including interleukin-6, interleukin-10, tumor necrosis factor-α, tumor necrosis factor-β, and C-reactive protein
Peripheral blood specimens will be collected, and plasma will be separated and stored according to standard procedures. Concentrations of inflammatory markers, including interleukin-6, interleukin-10, tumor necrosis factor-α, tumor necrosis factor-β, and C-reactive protein, will be measured using enzyme-linked immunosorbent assay (ELISA). Outcome data will be reported as mean or median plasma concentrations of each inflammatory marker by group or time point, and as between-group or within-subject changes from baseline. If additional inflammatory markers are measured, they will be listed and summarized in the same way.
Time frame: Before vaccine/placebo received and 28 days after 3 dose vaccine/placebo received
Adverse events
An adverse event is defined as any untoward medical occurrence in a participant after oral administration of vaccine or placebo, whether or not considered related to the study product. Adverse events may present as symptoms, signs, newly diagnosed diseases, or abnormal laboratory findings. Participants will be asked to actively report any adverse events during the follow-up period. Adverse events will be described by type, severity, timing, and relationship to the vaccine, if assessed.
Time frame: Within 7 days after vaccination or placebo administration
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Zhejiang Provincial Center for Disease Control and Prevention