Colorectal CancerPhase 4NCT07152886
The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer
A Phase 4 study testing Clostridium butyricum capsules in people with Colorectal Cancer and Chemotherapeutic Toxicity, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
This study is a multicenter randomized controlled trial designed to investigate the effects of Clostridium butyricum on adverse events during adjuvant treatment for colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer, Chemotherapeutic Toxicity
- What is being tested?
- Clostridium butyricum capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2025to 31 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years;
- No restriction on gender;
- Have completed radical resection for colorectal cancer (including open, laparoscopic, or robotic surgery), and assessed by the MDT as requiring adjuvant therapy primarily based on 5-FU and its derivatives or platinum-based regimens (including chemotherapy, targeted therapy, or radiotherapy);
- ECOG performance status score of 0-2;
- 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 that prevent cooperation with the intervention;
- Dysfunction of vital organs such as the liver, kidneys, or heart that renders the individual unsuitable for clinical research upon assessment, or inadequate bone marrow, liver, or renal function to undergo adjuvant therapy;
- Participation in other clinical studies within 3 months prior to enrollment;
- History of inflammatory bowel disease;
- History of autoimmune diseases;
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- Pregnancy or breastfeeding;
- Receipt of neoadjuvant therapy (including chemotherapy, radiotherapy, or targeted therapy) prior to surgery;
- Underwent ostomy surgery during the operation (including temporary or permanent ostomy).
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
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266071
Gan Liu
About this study
Official title: The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
This study is a multicenter randomized controlled trial designed to investigate the effects of Clostridium butyricum on adverse events during adjuvant treatment for colorectal cancer.
Read the detailed description
A total of 238 participants who have undergone radical resection for colorectal cancer and are scheduled to initiate adjuvant chemotherapy will be enrolled and randomly assigned in a 1:1 ratio to the intervention group or the control group. During adjuvant chemotherapy, participants in the intervention group will receive Clostridium butyricum capsules, while those in the control group will receive a placebo. The primary outcome is the incidence of CTCAE grade 3-4 diarrhea during adjuvant chemotherapy.
- Conditions
- Colorectal Cancer, Chemotherapeutic Toxicity
- Being tested
- Clostridium butyricum capsules, placebo capsules
- Keywords
- Colorectal Cancer, adjuvant chemotherapy, Clostridium butyricum
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clostridium butyricum capsulesDrug
Clostridium butyricum capsules , 6 capsules tid (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum).
placebo capsulesOther
Oral administration of placebo capsules, 6 capsules tid., containing corn starch. The appearance and weight of the placebo capsules are identical to those of intervention group.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Oral administration of Clostridium butyricum capsules during adjuvant chemotherapy, 6 capsules tid. (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum). Receives: Drug: Clostridium butyricum capsules |
| control group | Placebo comparator | Oral administration of placebo capsules, 6 capsules three times daily, containing corn starch. The appearance and weight of the placebo capsules are identical to those of intervention group. Receives: Other: placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTCAE grade 3-4 diarrhea
Incidence of grade 3-4 diarrhea during adjuvant chemotherapy, with severity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Measured: Throughout the entire course of adjuvant chemotherapy , up to 6 months
Secondary outcomes (10)
Overall incidence of adverse events
Overall incidence of adverse events during adjuvant chemotherapy. Severity and specific types will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Measured: Throughout the entire course of adjuvant chemotherapy , up to 6 months
rate of adjuvant treatment interruption
defined as a delay of >=3 weeks from the planned treatment schedule
Measured: Throughout the entire course of adjuvant chemotherapy , up to 6 months
White blood cell count
Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
Measured: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.
neutrophil count
Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
Measured: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.
lymphocyte count
Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
Measured: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.
C-reactive protein
Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
Measured: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.
procalcitonin
Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
Measured: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.
serum albumin
Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
Measured: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.
serum procalcitonin
Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
Measured: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.
completion rate of the planned adjuvant therapy
The total number of adjuvant chemotherapy cycles will be determined by the MDT (Multidisciplinary Team) prior to the initiation of treatment. Completion of the planned number of cycles as specified will be defined as "completed."
Measured: Throughout the entire course of adjuvant chemotherapy , up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start31 Oct 2025 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Linyi People's Hospital, Shandong Cancer Hospital and Institute, Yantai Yuhuangding Hospital, Jining First People's Hospital, Rizhao People's Hospital, Qianfoshan Hospital, Weifang People's Hospital, Qilu Hospital of Shandong University, Taian City Central Hospital, The Affiliated Hospital of Shandong Second Medical University, Dongying People's Hospital
- Responsible party
- Principal investigator, Zhou Yanbing, The Affiliated Hospital of Qingdao University
- Investigators
- Yanbing Zhou, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152886
- Sponsor's protocol ID
- DHQDFY-02
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 3 Sep 2025
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07152886
- Acronym / sponsor ID
- DHQDFY-02
- Conditions
- Colorectal Cancer, Chemotherapeutic Toxicity
- Keywords
- Colorectal Cancer, adjuvant chemotherapy, Clostridium butyricum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Linyi People's Hospital, Shandong Cancer Hospital and Institute, Yantai Yuhuangding Hospital, Jining First People's Hospital, Rizhao People's Hospital, Qianfoshan Hospital, Weifang People's Hospital, Qilu Hospital of Shandong University, Taian City Central Hospital, The Affiliated Hospital of Shandong Second Medical University, Dongying People's Hospital
- Study start
- 31 Oct 2025 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 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.
This study is a multicenter randomized controlled trial designed to investigate the effects of Clostridium butyricum on adverse events during adjuvant treatment for colorectal cancer.
Detailed description
A total of 238 participants who have undergone radical resection for colorectal cancer and are scheduled to initiate adjuvant chemotherapy will be enrolled and randomly assigned in a 1:1 ratio to the intervention group or the control group. During adjuvant chemotherapy, participants in the intervention group will receive Clostridium butyricum capsules, while those in the control group will receive a placebo. The primary outcome is the incidence of CTCAE grade 3-4 diarrhea during adjuvant chemotherapy.
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 |
|---|---|---|
| intervention group | Experimental | Drug: Clostridium butyricum capsulesOral administration of Clostridium butyricum capsules during adjuvant chemotherapy, 6 capsules tid. (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum). |
| control group | Placebo comparator | Other: placebo capsulesOral administration of placebo capsules, 6 capsules three times daily, containing corn starch. The appearance and weight of the placebo capsules are identical to those of intervention group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-70 years;
- No restriction on gender;
- Have completed radical resection for colorectal cancer (including open, laparoscopic, or robotic surgery), and assessed by the MDT as requiring adjuvant therapy primarily based on 5-FU and its derivatives or platinum-based regimens (including chemotherapy, targeted therapy, or radiotherapy);
- ECOG performance status score of 0-2;
- Signed informed consent
Key exclusion criteria (9 listed)
- Use of probiotics, prebiotics, synbiotics, or antibiotics within 2 weeks prior to enrollment;
- Presence of psychiatric disorders or other conditions that prevent cooperation with the intervention;
- Dysfunction of vital organs such as the liver, kidneys, or heart that renders the individual unsuitable for clinical research upon assessment, or inadequate bone marrow, liver, or renal function to undergo adjuvant therapy;
- Participation in other clinical studies within 3 months prior to enrollment;
- History of inflammatory bowel disease;
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 capsulesClostridium butyricum capsules , 6 capsules tid (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum). | Drug | intervention group |
| placebo capsulesOral administration of placebo capsules, 6 capsules tid., containing corn starch. The appearance and weight of the placebo capsules are identical to those of intervention group. | Other | control group |
Primary outcome
CTCAE grade 3-4 diarrhea
Time frame: Throughout the entire course of adjuvant chemotherapy , up to 6 months
Incidence of grade 3-4 diarrhea during adjuvant chemotherapy, with severity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
10 secondary outcomes
Overall incidence of adverse events
Time frame: Throughout the entire course of adjuvant chemotherapy , up to 6 months
rate of adjuvant treatment interruption
Time frame: Throughout the entire course of adjuvant chemotherapy , up to 6 months
White blood cell count
Time frame: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.
neutrophil count
Time frame: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.
lymphocyte count
Time frame: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.
C-reactive protein
Time frame: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.
procalcitonin
Time frame: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.
serum albumin
Time frame: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.
serum procalcitonin
Time frame: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.
completion rate of the planned adjuvant therapy
Time frame: Throughout the entire course of adjuvant chemotherapy , up to 6 months
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 3 Sep 2025.
- 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 principal investigator
The Affiliated Hospital of Qingdao University
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 Clostridium butyricum capsules in people with Colorectal Cancer and Chemotherapeutic Toxicity, run by The Affiliated Hospital of Qingdao University 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 5 inclusion and 9 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 3 Sep 2025. 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 Gan Liu (18866799842, docliu163@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTCAE grade 3-4 diarrhea (time frame: Throughout the entire course of adjuvant chemotherapy , up to 6 months). 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 3 Sep 2025.