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.
Trial summary
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… Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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
Show all 13Show fewer
- 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.
China1 site
Ningbo Haishu District Dongqiao Town Health Center
Ningbo, Zhejiang, 315000
Gao, +86 057187115167, kgao@cdc.zj.cn
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.
Read more
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and Prevention
- Sponsor type
- Other government
- Collaborators
- Shanghai United Cell Biotechnology Co., Ltd
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07873346
- Acronym / sponsor ID
- 2026-053-01
- Conditions
- Bowel Habits, Gut Microbiomes, Inflamatory Markers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and PreventionOther government
- Collaborators
- Shanghai United Cell Biotechnology Co., Ltd
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Other: PlaceboAdministration of placebo |
| treatment group | Experimental | Drug: Receive recombinant B-subunit/whole-cell cholera vaccineReceive recombinant B-subunit/whole-cell cholera vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receive recombinant B-subunit/whole-cell cholera vaccineParticipants in this group will receive the oral cholera vaccine according to the manufacturer's recommended schedule (3 dose, at 0d, 7d, 28d). | Drug | treatment group |
| PlaceboParticipants in this group will receive a placebo that looks identical to the vaccine but contains no active ingredient (3 dose, at 0d, 7d, 28d). | Other | placebo group |
Primary outcome
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
Time frame: Before vaccine/placebo received and 28 days after 3 dose vaccine/placebo received
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.
Bowel habits
Time frame: Before vaccine/placebo received and 28 days after 3 dose vaccine/placebo received
A questionnaire survey will be conducted on bowel habits over the past month (stool consistency, defecation frequency, and defecation time).
Plasma levels of inflammatory markers, including interleukin-6, interleukin-10, tumor necrosis factor-α, tumor necrosis factor-β, and C-reactive protein
Time frame: Before vaccine/placebo received and 28 days after 3 dose vaccine/placebo received
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.
1 secondary outcome
Adverse events
Time frame: Within 7 days after vaccination or placebo administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Gao (+86 057187115167, kgao@cdc.zj.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Before vaccine/placebo received and 28 days after 3 dose vaccine/placebo received). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.