Colorectal AdenomaPhase 4NCT07167342
The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma
A Phase 4 study testing Clostridium butyricum capsules, Live in people with Colorectal Adenoma and Probiotics, run by The Affiliated Hospital of Qingdao University at 2 sites in China.
Trial summary
The prevention of recurrence after colorectal adenoma resection remains an urgent medical issue to be addressed. Previous studies have mainly focused on nonsteroidal anti-inflammatory drugs, calcium supplements, and vitamins. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Adenoma, Probiotics
- What is being tested?
- Clostridium butyricum capsules, Live
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 2 sitesChina
- Study dates
- 22 May 2026to 30 Apr 2030
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- No restriction on sex
- Boston Bowel Preparation Score (BBPS) ≥ 7 prior to endoscopic procedure
- Completed endoscopic resection of colorectal adenomas (including cold snare polypectomy, ESD, EMR, etc.) with no residual adenomas or polyps observed endoscopically
- Histologically confirmed adenomas (including tubular, villous, or tubulovillous types) without malignant transformation
- Able to take oral medication
- Signed informed consent
Who cannot join
- Use of probiotics, prebiotics, synbiotics, or antibiotics within 2 weeks prior to enrollment
- Presence of psychiatric disorders or other conditions preventing compliance with the intervention
- Dysfunction of vital organs (liver, kidney, heart, etc.) deemed unsuitable for clinical study participation after evaluation
- Participation in other clinical trials within 3 months prior to enrollment
- History of gastrointestinal surgery (excluding endoscopic procedures)
- History of inflammatory bowel disease
Show all 11Show fewer
- History of autoimmune diseases
- Long-term use of aspirin (≥100 mg/day for over 3 months) or calcium supplements (≥1200 mg/day for over 3 months)
- Pregnancy or breastfeeding
- Previous treatment for colorectal adenomas (including endoscopic or surgical resection)
- Familial adenomatous polyposis (FAP)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
the Affiliated Hospital of QIngdao University
Qingdao, Shandong, 266000
Gan Liu, +86 18866799842, docliu163@163.com
yanbing Zhou, zhouyanbing@qduhospital.cn
- Recruiting
Weifang People's Hospital
Weifang, Shandong
Junxi Sun, 13573667956, sjx1971@sina.com
About this study
Official title: The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma - A Multicenter, Double-blinded, Differential Design, Randomized, Placebo-controlled Study
The prevention of recurrence after colorectal adenoma resection remains an urgent medical issue to be addressed. Previous studies have mainly focused on nonsteroidal anti-inflammatory drugs, calcium supplements, and vitamins. The gut microbiota and its metabolic products are believed to play a potential role in the development and progression of colorectal adenomas. Clostridium butyricum, a butyrate-producing probiotic, has not yet been studied for its potential in preventing the recurrence of colorectal adenomas following resection. Therefore, this study, designed as a multicenter, double-blind, placebo-controlled randomized controlled trial, aims to explore evidence-based data on the role of Clostridium butyricum in preventing colorectal adenoma recurrence.
Read the detailed description
Statistical Analysis Plan the intention-to-treat (ITT) population (all randomized participants analyzed according to the randomized assignment)-the primary analysis set; the per-protocol (PP) population (participants with ≥80% treatment compliance and no major protocol violations)-used for confirmatory efficacy consistency testing; and the safety analysis (SA) population (all randomized participants exposed to the investigational product or placebo with post-intervention safety data)-used for all safety evaluations.
Primary Outcome Analysis Due to the asymptomatic nature of colorectal adenoma recurrence, which can only be detected at scheduled annual colonoscopic examinations, the time to recurrence is considered interval-censored data (i.e., the exact recurrence time is unknown, only that it occurred within a 12-month window between two consecutive colonoscopies). Given this data characteristic, the 3-year cumulative CRA recurrence rate will be estimated using the life table method, which divides follow-up time into 12-month intervals (0-12, 12-24, 24-36 months). Between-group comparisons of recurrence-free survival will be performed using the stratified log-rank test (stratified by participating center). Hazard ratios (HR) and corresponding 95% confidence intervals (CIs) will be estimated using a stratified Cox proportional hazards model. To ensure the robustness of the findings, sensitivity analyses using the Turnbull algorithm (an extension of the Kaplan-Meier method for interval-censored data) will also be conducted.
- Conditions
- Colorectal Adenoma, Probiotics
- Being tested
- Clostridium butyricum capsules, Live, Control (placebo)
- Keywords
- Colorectal Adenoma, Clostridium butyricum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clostridium butyricum capsules, LiveDrug
Oral Clostridium butyricum capsules, Live: take 3 capsules twice daily (bid) for the first 3 months after adenoma resection, then continue with 3 capsules once daily (qd) until 3 years post-resection (each capsule contains ≥6.3 × 10⁶ CFU of Clostridium butyricum).
Control (placebo)Other
Placebo capsules containing corn starch, with identical appearance, weight, and administration method as the treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Clostridium butyricum group | Experimental | Oral Clostridium butyricum capsules, Live: take 3 capsules twice daily (bid) for the first 3 months after adenoma resection, then continue with 3 capsules once daily (qd) until 3 years post-resection (each capsule contains ≥6.3 × 10⁶ CFU of Clostridium butyricum). Receives: Drug: Clostridium butyricum capsules, Live |
| Placebo group | Placebo comparator | Placebo capsules containing corn starch, with identical appearance, weight, and administration method as the study group. Receives: Other: Control (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 3-year cumulative recurrence rate of CRA
The 3-year cumulative recurrence rate of CRA following colonoscopic resection. Recurrence is defined as the identification of new or residual adenomatous polyps in the colorectum on colonoscopy during the follow-up period, confirmed pathologically.
Measured: 3 years
Secondary outcomes (8)
1-year and 2 year adenoma recurrence rate
Each subject will undergo a colonoscopy once per year after enrollment to monitor for adenoma recurrence.
Measured: 1-year and 2-year after enrollment
incidence of colorectal cancer
Each subject will undergo a colonoscopy once per year after enrollment to monitor for the development of colorectal cancer.
The incidence of colorectal cancer is calculated as:
Incidence (%) = (Number of subjects diagnosed with colorectal cancer / Total number of subjects) × 100%
Measured: 3 years after enrollment
Incidence of advanced colorectal adenomas
Each subject will undergo a colonoscopy once per year after enrollment to monitor for the presence of advanced adenomas.
The incidence of advanced adenomas is calculated as:
Incidence (%) = (Number of subjects with advanced adenomas / Total number of subjects) × 100%
Advanced colorectal adenoma is diagnosed when any of the following criteria are met: Adenoma diameter ≥ 10 mm，Villous component ≥ 25%，Presence of high-grade intraepithelial neoplasia.
Measured: 3 years after enrollment
Location of adenoma recurrence
Classify the locations according to ascending colon, transverse colon, descending colon, sigmoid colon, and rectum.
Measured: 3 years
Number of recurrent adenomas
Measured: 3 years
Histological classification of recurrent adenomas
Classify the locations according to Tubular adenoma, Villous adenoma, Tubulovillous adenoma, Serrated adenoma
Measured: 3 years
Size of recurrent adenomas
Measure the maximum diameter of the adenoma in millimeters
Measured: 3 years
adenoma burden
Adenoma burden: the sum of the maximum diameters of all recurrent adenomas detected during follow-up.
Measured: Assessed at 12, 24, and 36 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start22 May 2026
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Cancer Hospital and Institute, Yantai Yuhuangding Hospital, Rizhao People's Hospital, Qianfoshan Hospital, Weifang People's Hospital, Dongying People's Hospital, Peking University People's Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, The First Affiliated Hospital of Bengbu Medical University
- Responsible party
- Principal investigator, Zhou Yanbing, The Affiliated Hospital of Qingdao University
- Investigators
- yanbing Zhou, Study chair, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167342
- Sponsor's protocol ID
- GISSG2026-01
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma - A Multicenter, Double-blinded, Differential Design, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07167342
- Acronym / sponsor ID
- GISSG2026-01
- Conditions
- Colorectal Adenoma, Probiotics
- Keywords
- Colorectal Adenoma, Clostridium butyricum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Collaborators
- Shandong Cancer Hospital and Institute, Yantai Yuhuangding Hospital, Rizhao People's Hospital, Qianfoshan Hospital, Weifang People's Hospital, Dongying People's Hospital, Peking University People's Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, The First Affiliated Hospital of Bengbu Medical University
- Study start
- 22 May 2026 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 11 Sep 2025 (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.
The prevention of recurrence after colorectal adenoma resection remains an urgent medical issue to be addressed. Previous studies have mainly focused on nonsteroidal anti-inflammatory drugs, calcium supplements, and vitamins. The gut microbiota and its metabolic products are believed to play a potential role in the development and progression of colorectal adenomas. Clostridium butyricum, a butyrate-producing probiotic, has not yet been studied for its potential in preventing the recurrence of colorectal adenomas following resection. Therefore, this study, designed as a multicenter, double-blind, placebo-controlled randomized controlled trial, aims to explore evidence-based data on the role of Clostridium butyricum in preventing colorectal adenoma recurrence.
Detailed description
Statistical Analysis Plan the intention-to-treat (ITT) population (all randomized participants analyzed according to the randomized assignment)-the primary analysis set; the per-protocol (PP) population (participants with ≥80% treatment compliance and no major protocol violations)-used for confirmatory efficacy consistency testing; and the safety analysis (SA) population (all randomized participants exposed to the investigational product or placebo with post-intervention safety data)-used for all safety evaluations.
Primary Outcome Analysis Due to the asymptomatic nature of colorectal adenoma recurrence, which can only be detected at scheduled annual colonoscopic examinations, the time to recurrence is considered interval-censored data (i.e., the exact recurrence time is unknown, only that it occurred within a 12-month window between two consecutive colonoscopies). Given this data characteristic, the 3-year cumulative CRA recurrence rate will be estimated using the life table method, which divides follow-up time into 12-month intervals (0-12, 12-24, 24-36 months). Between-group comparisons of recurrence-free survival will be performed using the stratified log-rank test (stratified by participating center). Hazard ratios (HR) and corresponding 95% confidence intervals (CIs) will be estimated using a stratified Cox proportional hazards model. To ensure the robustness of the findings, sensitivity analyses using the Turnbull algorithm (an extension of the Kaplan-Meier method for interval-censored data) will also be conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clostridium butyricum group | Experimental | Drug: Clostridium butyricum capsules, LiveOral Clostridium butyricum capsules, Live: take 3 capsules twice daily (bid) for the first 3 months after adenoma resection, then continue with 3 capsules once daily (qd) until 3 years post-resection (each capsule contains ≥6.3 × 10⁶ CFU of Clostridium butyricum). |
| Placebo group | Placebo comparator | Other: Control (placebo)Placebo capsules containing corn starch, with identical appearance, weight, and administration method as the study group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 75 years
- No restriction on sex
- Boston Bowel Preparation Score (BBPS) ≥ 7 prior to endoscopic procedure
- Completed endoscopic resection of colorectal adenomas (including cold snare polypectomy, ESD, EMR, etc.) with no residual adenomas or polyps observed endoscopically
- Histologically confirmed adenomas (including tubular, villous, or tubulovillous types) without malignant transformation
Key exclusion criteria (11 listed)
- Use of probiotics, prebiotics, synbiotics, or antibiotics within 2 weeks prior to enrollment
- Presence of psychiatric disorders or other conditions preventing compliance with the intervention
- Dysfunction of vital organs (liver, kidney, heart, etc.) deemed unsuitable for clinical study participation after evaluation
- Participation in other clinical trials within 3 months prior to enrollment
- History of gastrointestinal surgery (excluding endoscopic procedures)
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 |
|---|---|---|
| Clostridium butyricum capsules, LiveOral Clostridium butyricum capsules, Live: take 3 capsules twice daily (bid) for the first 3 months after adenoma resection, then continue with 3 capsules once daily (qd) until 3 years post-resection (each capsule contains ≥6.3 × 10⁶ CFU of Clostridium butyricum). | Drug | Clostridium butyricum group |
| Control (placebo)Placebo capsules containing corn starch, with identical appearance, weight, and administration method as the treatment group. | Other | Placebo group |
Primary outcome
The 3-year cumulative recurrence rate of CRA
Time frame: 3 years
The 3-year cumulative recurrence rate of CRA following colonoscopic resection. Recurrence is defined as the identification of new or residual adenomatous polyps in the colorectum on colonoscopy during the follow-up period, confirmed pathologically.
8 secondary outcomes
1-year and 2 year adenoma recurrence rate
Time frame: 1-year and 2-year after enrollment
incidence of colorectal cancer
Time frame: 3 years after enrollment
Incidence of advanced colorectal adenomas
Time frame: 3 years after enrollment
Location of adenoma recurrence
Time frame: 3 years
Number of recurrent adenomas
Time frame: 3 years
Histological classification of recurrent adenomas
Time frame: 3 years
Size of recurrent adenomas
Time frame: 3 years
adenoma burden
Time frame: Assessed at 12, 24, and 36 months post-enrollment
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 26 May 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.
yanbing Zhou study chair
The Affiliated Hospital of Qingdao University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clostridium butyricum capsules, Live in people with Colorectal Adenoma and Probiotics, run by The Affiliated Hospital of Qingdao University at 2 sites 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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Gan Liu (+86 18866799842, docliu163@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 3-year cumulative recurrence rate of CRA (time frame: 3 years). 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 26 May 2026.