Chemotherapy-induced DiarrheaNCT07309315
Inactivated Bacteroides Fragilis for Prevention of Chemotherapy-Induced Diarrhea
A study testing Inactivated Bacteroides fragilis in people with Chemotherapy-induced Diarrhea, run by Shenzhen Hospital of Southern Medical University at 1 site in China.
Trial summary
The incidence of chemotherapy-induced diarrhea (CID) is closely related to the types of anticancer drugs. Combination chemotherapy regimens such as fluorouracil derivatives and irinotecan, as well as tyrosine kinase inhibitors like neratinib, are associated with a high severity and incidence of diarrhea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Diarrhea
- What is being tested?
- Inactivated Bacteroides fragilis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2026to 30 Dec 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form, be able to comply with the protocol and have the capacity to complete relevant procedures.
- Aged ≥ 18 years old (based on the date of signing the ICF), regardless of gender.
- Patients with malignant tumors confirmed by pathology or cytology.
- Patients scheduled to receive the following initial treatments at the standard dose specified in the protocol:
- Cohort 1: Patients with advanced colorectal cancer receiving the FOLFIRI regimen (irinotecan + fluorouracil + leucovorin);
- Cohort 2: Patients with breast cancer receiving neratinib treatment.
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- ECOG performance status score of 0-1 at the start of the study.
- Expected survival time ≥ 12 weeks.
- Subjects of childbearing potential (including males and females) agree to adopt effective contraceptive measures approved by the investigators (e.g., intrauterine device, contraceptive pills or condoms) during the trial and within 3 months after the trial ends. Female subjects of childbearing potential must have a negative result in serum human chorionic gonadotropin (hCG) test.
Who cannot join
- History of altered bowel habits or abnormal stool characteristics prior to screening that, in the investigator's opinion, would preclude subsequent efficacy evaluation; or use of laxatives within 7 days prior to randomization; or use of antidiarrheal agents within 48 hours prior to randomization.
- Complicated with diseases causing diarrhea, including but not limited to inflammatory bowel disease (e.g., ulcerative colitis and Crohn's disease), suspected or confirmed infectious diarrhea, irritable bowel syndrome, celiac disease, etc.
- Receipt of any chemotherapeutic agents or PD-1 antibodies other than the chemotherapy/treatment regimen specified in the protocol during the trial.
- Concurrent abdominopelvic radiotherapy during the trial period; or unresolved radiotherapy-induced enteritis caused by previous abdominopelvic radiotherapy.
- Medical history of chronic use of laxatives (≥ 30 non-consecutive days).
- Need for antibiotic treatment during the trial or long-term use of antibiotics prior to randomization.
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- Patients with stomas, including temporary stomas that have not been closed or patients whose bowel function has not recovered after stoma closure.
- Presence of unhealed surgical wounds, ulcers or fractures.
- Known history of human immunodeficiency virus (HIV) infection (positive HIV antibody test).
- History of allergy or suspected allergy to antidiarrheal drugs (e.g., loperamide and its components).
- Suspected or confirmed history of alcohol or drug abuse.
- Pregnant or lactating women.
- Concurrent participation in other clinical trials.
- Other conditions deemed inappropriate for study participation by the investigator.
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, 1 recruiting
- Recruiting
Shenzhen Hospital, Southern Medical University
Shenzhen, Guangdong, 518005
wei H Zhou, MD, 18688489622, zhw811807859@126.com
About this study
The incidence of chemotherapy-induced diarrhea (CID) is closely related to the types of anticancer drugs. Combination chemotherapy regimens such as fluorouracil derivatives and irinotecan, as well as tyrosine kinase inhibitors like neratinib, are associated with a high severity and incidence of diarrhea. These All antineoplastic agents can induce intestinal epithelial cell apoptosis, damage the intestinal mucosa, subsequently reduce the absorption surface area, and thereby lead to diarrhea. Recent literature has indicated that Bacteroides fragilis may be a candidate drug for the treatment and prevention of CID. This study intends to conduct a randomized controlled trial to determine the efficacy and mechanism of action of inactivated Bacteroides fragilis (SK10) in the prevention of chemotherapy-induced diarrhea (CID).
- Conditions
- Chemotherapy-induced Diarrhea
- Being tested
- Inactivated Bacteroides fragilis, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Bacteroides fragilisDrug
Also called SK10
Live Biotherapeutic Products
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Trial Group of Patients with Advanced Colorectal Cancer Receives: Drug: Inactivated Bacteroides fragilis |
| Arm 2 | Placebo comparator | Control Group of Patients with Advanced Colorectal Cancer Receives: Drug: Placebo |
| Arm 3 | Experimental | Trial Group of Patients with Breast Cancer Receives: Drug: Inactivated Bacteroides fragilis |
| Arm 4 | Placebo comparator | Control Group of Patients with Breast Cancer Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Incidence of Diarrhea
Proportion of Patients with Any Grade of Diarrhea assessed by CTCAE v5.0
Measured: 4 weeks
Secondary outcomes (12)
Incidence of Grade ≥2 Diarrhea
Proportion of Patients with Grade 2 or Higher Diarrhea assessed by CTCAE v5.0
Measured: 4 weeks
Incidence of Grade ≥3 Diarrhea
Proportion of Patients with Grade 2 or Higher Diarrhea assessed by CTCAE v5.0
Measured: 4 weeks
Days of Diarrhea
Mean Days of Diarrhea per Treatment Cycle
Measured: 4 weeks
Frequency of Diarrhea
Mean Frequency of Stool Type 6 or 7 per Treatment Cycle
Measured: 4 weeks
Percentage and Days of Patients Receiving Antidiarrheal Treatment
Percentage of patients treated with antidiarrheal drugs (loperamide, diphenoxylate, octreotide, montmorillonite), defined as the proportion of patients with at least one dose of antidiarrheal drugs relative to the total number of cases; days of antidiarrheal treatment, defined as the mean days of antidiarrheal drug administration per treatment cycle.
Measured: 4 weeks
Proportion of Patients Who Received Medical Treatment for Diarrhea
Proportion of patients who sought medical attention due to diarrhea and received intravenous fluid replacement or anti-infective treatment from investigators.
Measured: 4 weeks
Proportion of Patients Who Had Chemotherapy/Treatment Dose Reduction, Delay or Discontinuation Due to Diarrhea
Proportion of patients with chemotherapy/treatment dose reduction, delay or discontinuation as judged by investigators due to diarrhea.
Measured: 4 weeks
Relative Dose Intensity of Chemotherapy/Treatment
Ratio of delivered dose intensity (mg/m² or mg) to planned dose intensity (mg/m² or mg)
Measured: 4 weeks
Incidence of Other Gastrointestinal Symptoms
Proportion of patients with at least one episode of any grade of gastrointestinal symptoms (constipation, abdominal distension, abdominal pain, hematochezia, nausea, vomiting) assessed by CTCAE v5.0.
Measured: 4 weeks
Change in Quality of Life Score of Cancer Patients Compared with Baseline
Defined as the change in the QLQ-C30 quality of life scale score of cancer patients after study intervention compared with the baseline.
Measured: 4 weeks
Incidence of Adverse Event (AE)
Proportion of participants with adverse events as assessed by CTCAE v5.0
Measured: 4 weeks
Incidence of Serious Adverse Event (SAE)
Proportion of participants with Serious Adverse Event (SAE) as assessed by GCP 2020
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start13 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced DiarrheaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hospital of Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Zhou, Shenzhen Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309315
- Sponsor's protocol ID
- SK10-IIT
- Status last verified
- Jun 2026
- First submitted
- 12 Dec 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inactivated Bacteroides Fragilis for Prevention of Chemotherapy-Induced Diarrhea
- ClinicalTrials.gov ID
- NCT07309315
- Acronym / sponsor ID
- SK10-IIT
- Conditions
- Chemotherapy-induced Diarrhea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shenzhen Hospital of Southern Medical UniversityUniversity, hospital or other
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Dec 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 incidence of chemotherapy-induced diarrhea (CID) is closely related to the types of anticancer drugs. Combination chemotherapy regimens such as fluorouracil derivatives and irinotecan, as well as tyrosine kinase inhibitors like neratinib, are associated with a high severity and incidence of diarrhea. These All antineoplastic agents can induce intestinal epithelial cell apoptosis, damage the intestinal mucosa, subsequently reduce the absorption surface area, and thereby lead to diarrhea. Recent literature has indicated that Bacteroides fragilis may be a candidate drug for the treatment and prevention of CID. This study intends to conduct a randomized controlled trial to determine the efficacy and mechanism of action of inactivated Bacteroides fragilis (SK10) in the prevention of chemotherapy-induced diarrhea (CID).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Inactivated Bacteroides fragilisTrial Group of Patients with Advanced Colorectal Cancer |
| Arm 2 | Placebo comparator | Drug: PlaceboControl Group of Patients with Advanced Colorectal Cancer |
| Arm 3 | Experimental | Drug: Inactivated Bacteroides fragilisTrial Group of Patients with Breast Cancer |
| Arm 4 | Placebo comparator | Drug: PlaceboControl Group of Patients with Breast Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily sign the informed consent form, be able to comply with the protocol and have the capacity to complete relevant procedures.
- Aged ≥ 18 years old (based on the date of signing the ICF), regardless of gender.
- Patients with malignant tumors confirmed by pathology or cytology.
- Patients scheduled to receive the following initial treatments at the standard dose specified in the protocol:
- ECOG performance status score of 0-1 at the start of the study.
Key exclusion criteria (14 listed)
- History of altered bowel habits or abnormal stool characteristics prior to screening that, in the investigator's opinion, would preclude subsequent efficacy evaluation; or use of laxatives within 7 days prior to randomization; or use of antidiarrheal agents within 48 hours prior to randomization.
- Complicated with diseases causing diarrhea, including but not limited to inflammatory bowel disease (e.g., ulcerative colitis and Crohn's disease), suspected or confirmed infectious diarrhea, irritable bowel syndrome, celiac disease, etc.
- Receipt of any chemotherapeutic agents or PD-1 antibodies other than the chemotherapy/treatment regimen specified in the protocol during the trial.
- Concurrent abdominopelvic radiotherapy during the trial period; or unresolved radiotherapy-induced enteritis caused by previous abdominopelvic radiotherapy.
- Medical history of chronic use of laxatives (≥ 30 non-consecutive days).
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 |
|---|---|---|
| Inactivated Bacteroides fragilisAlso: SK10Live Biotherapeutic Products | Drug | Arm 1, Arm 3 |
| PlaceboPlacebo | Drug | Arm 2, Arm 4 |
Primary outcome
Overall Incidence of Diarrhea
Time frame: 4 weeks
Proportion of Patients with Any Grade of Diarrhea assessed by CTCAE v5.0
12 secondary outcomes
Incidence of Grade ≥2 Diarrhea
Time frame: 4 weeks
Incidence of Grade ≥3 Diarrhea
Time frame: 4 weeks
Days of Diarrhea
Time frame: 4 weeks
Frequency of Diarrhea
Time frame: 4 weeks
Percentage and Days of Patients Receiving Antidiarrheal Treatment
Time frame: 4 weeks
Proportion of Patients Who Received Medical Treatment for Diarrhea
Time frame: 4 weeks
Proportion of Patients Who Had Chemotherapy/Treatment Dose Reduction, Delay or Discontinuation Due to Diarrhea
Time frame: 4 weeks
Relative Dose Intensity of Chemotherapy/Treatment
Time frame: 4 weeks
Incidence of Other Gastrointestinal Symptoms
Time frame: 4 weeks
Change in Quality of Life Score of Cancer Patients Compared with Baseline
Time frame: 4 weeks
Incidence of Adverse Event (AE)
Time frame: 4 weeks
Incidence of Serious Adverse Event (SAE)
Time frame: 4 weeks
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 5 Jun 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 study testing Inactivated Bacteroides fragilis in people with Chemotherapy-induced Diarrhea, run by Shenzhen Hospital of Southern Medical 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 9 inclusion and 14 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 5 Jun 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.
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 Zhou (18688489622, zhw811807859@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Incidence of Diarrhea (time frame: 4 weeks). 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 5 Jun 2026.