Bowel HabitsPhase 4NCT07873346

Study on Changes in Gut Microbiota, Inflammatory Factors, and Bowel Habits Following Oral Administration of Recombinant B-subunit/Whole Cell Cholera Vaccine in a Community Population

A Phase 4 study testing Receive recombinant B-subunit/whole-cell cholera vaccine in people with Bowel Habits and Gut Microbiomes, run by Zhejiang Provincial Center for Disease Control and Prevention at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Bowel Habits, Gut Microbiomes, Inflamatory Markers
What is being tested?: Receive recombinant B-subunit/whole-cell cholera vaccine
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 1 siteChina
Study dates: 20 Oct 2026to 30 Dec 2027
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Local permanent residents aged 18 years or older, regardless of gender
Axillary temperature <37°C on the day of vaccination
No prior history of cholera vaccine administration, or ≥2 years since the last dose of cholera vaccine
Ability to understand the study content and procedures, sign the informed consent form, and cooperate in completing the study

Who cannot join

Individuals with febrile illness (axillary temperature ≥37.0℃ on the day of vaccination), other acute diseases, or diarrheal disease within 7 days before vaccination
Use of antibiotics within 14 days before vaccination, or requiring long-term antibiotic use
Severe hypertension, severe heart, liver, or kidney diseases, or severe infectious diseases such as AIDS or active tuberculosis
History or family history of convulsions, encephalopathy, psychosis, uncontrolled epilepsy, or other progressive neurological diseases; history of Guillain-Barré syndrome
Contraindications to vaccination, or history of allergic reactions to previous vaccinations
Receipt of blood products within 3 months before vaccination

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Receipt of other investigational products within 30 days before vaccination
Receipt of any rotavirus vaccine within 12 months before vaccination
Receipt of a live attenuated vaccine within 14 days before vaccination, or an inactivated or subunit vaccine within 7 days before vaccination
Females who are pregnant, lactating, or planning to become pregnant during the study
Individuals who, in the investigator's judgment, are unsuitable for participation due to medical, psychological, social, or other conditions that may compromise compliance with the study protocol or affect the ability to provide informed consent
Allergic reaction or serious adverse event causally related to the study vaccine at the first or second vaccination
Occurrence of any of the exclusion criteria for the first oral vaccination after enrollment (except for antibiotic use after the first dose)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kai Gao contact

+86 057187115167

kgao@cdc.zj.cn

China1 site

Ningbo Haishu District Dongqiao Town Health Center
Ningbo, Zhejiang, 315000
Gao, +86 057187115167, kgao@cdc.zj.cn

Other trials in China

About this study

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.

Conditions: Bowel Habits, Gut Microbiomes, Inflamatory Markers
Being tested: Receive recombinant B-subunit/whole-cell cholera vaccine, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Receive recombinant B-subunit/whole-cell cholera vaccineDrug
Participants in this group will receive the oral cholera vaccine according to the manufacturer's recommended schedule (3 dose, at 0d, 7d, 28d).
PlaceboOther
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).

Study groups in NCT07873346
Study group	Role	What they receive
placebo group	Placebo comparator	Administration of placebo Receives: Other: Placebo
treatment group	Experimental	Receive recombinant B-subunit/whole-cell cholera vaccine Receives: Drug: Receive recombinant B-subunit/whole-cell cholera vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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.
Measured: Before vaccine/placebo received and 28 days after 3 dose vaccine/placebo received

Secondary outcomes (1)

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.
Measured: Within 7 days after vaccination or placebo administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 202630 Dec 2027

First posted14 Oct 2026
Study start20 Oct 2026 (estimated)
Primary completion30 Jun 2027 (estimated)
Study completion30 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bowel HabitsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07873346
Sponsor's protocol ID: 2026-053-01
Status last verified: Oct 2026
First submitted: 22 Sep 2026
Last updated: 14 Oct 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No