Fecal Microbiota Transplantation (FMT)Phase 1NCT07319364
A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects
A Phase 1 study testing Fecal microbiota transplantation (FMT) in people with Fecal Microbiota Transplantation (FMT) and Gastrointestinal Neoplasms, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if fecal microbiota transplantation can treat in Gastrointestinal cancer patients with chemotherapy / targeted gastrointestinal symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Microbiota Transplantation (FMT), Gastrointestinal Neoplasms, Antineoplastic Agents
- What is being tested?
- Fecal microbiota transplantation (FMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Sep 2026
- Phase
- Phase 1
- 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
- Age ≥ 18 years, gender not restricted;
- Estimated survival time ≥ 3 months;
- Confirmed diagnosis of gastrointestinal tumors by pathological examination, including esophageal cancer, gastric cancer, colon cancer, rectal cancer, etc.;
- TNM staging of cancer in patients is Stage IV;
- Having undergone PD-1 or PD-L1 testing;
- Planned to receive the 4th cycle of chemotherapy/targeted therapy;
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- Occurrence of gastrointestinal adverse reactions (including but not limited to diarrhea, constipation, vomiting, nausea, etc.) within 3 cycles of conventional chemotherapy/targeted therapy;
- Patients are able and willing to sign the informed consent form and complete follow-up;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
- Use of oral/intravenous broad-spectrum antibiotics with caution within 3 days;
- Patients are able to swallow capsules without chewing;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;
- Laboratory test results during the screening period indicate that the subjects have sufficient organ function.
Who cannot join
- Patients with major organ dysfunction or even failure, including but not limited to cardiac insufficiency or heart failure, renal insufficiency or renal failure, and hepatic insufficiency/hepatic failure;
- Uncontrolled or severe infections;
- Known history of psychotropic substance abuse, alcoholism, and drug abuse;
- Patients with severe infections complicated with septicemia or sepsis;
- Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules;
- Patients with active viral infections;
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- Female subjects with a positive pregnancy test, lactating female subjects, and women of childbearing age who refuse to use contraceptive measures during the entire observation period (15 weeks);
- Patients with gastrointestinal perforation and/or fistula;
- Other conditions deemed unsuitable for enrollment 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
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, Hangzhou, 310009
Da Wang, 8613819108162, wangda0618@zju.edu.cn
About this study
Official title: An Observational, Real-World Study Evaluating Fecal Microbiota Transplantation for the Prevention/Reduction of Chemotherapy/Targeted Therapy-Induced Gastrointestinal Symptoms in Patients With Gastrointestinal Cancers.
The goal of this clinical trial is to learn if fecal microbiota transplantation can treat in Gastrointestinal cancer patients with chemotherapy / targeted gastrointestinal symptoms. The main question it aims to answer is: To evaluate the effect of fecal microbiota transplantation (FMT) on gastrointestinal tract in patients with gastrointestinal tumors.
- Conditions
- Fecal Microbiota Transplantation (FMT), Gastrointestinal Neoplasms, Antineoplastic Agents, Drug-related Side Effects and Adverse Reactions
- Being tested
- Fecal microbiota transplantation (FMT)
- Keywords
- Fecal Microbiota Transplantation, Gastrointestinal Neoplasms, Antineoplastic Agents, Drug-Related Side Effects and Adverse Reactions
- Medical subject headings
- Gastrointestinal Neoplasms, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation (FMT)Biological
Also called Chemotherapy, Targeted Therapy
Building upon the existing treatment regimen, starting from the fourth cycle, one FMT treatment was administered within 3 days prior to chemotherapy/targeted therapy during the fourth, sixth, and eighth cycles (weeks 3, 9, and 15 after study initiation). Each transplant consisted of approximately 40g of donor intestinal bacteria encapsulated in capsules. The capsules were administered orally, typically at a dose of 2-3 capsules (1g/capsule) every 3-5 minutes, totaling 40 capsules per dose for a total of 120 capsules. Treatment cycles were conducted every 3 weeks, with therapeutic efficacy assessed after every 2 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients in the control group continued their original chemotherapy/targeted therapy regimen, with each treatment cycle lasting 3 weeks, for a total of 5 cycles. Treatment efficacy was assessed after every 2 cycles. |
| Experimental Group | Experimental | Patients in the FMT group received treatment starting from the fourth cycle on top of their existing regimen. They underwent one FMT treatment within 3 days prior to chemotherapy/targeted therapy during the fourth, sixth, and eighth cycles (weeks 3, 9, and 15 after study initiation). Each transplant consisted of approximately 40g of donor gut microbiota encapsulated in capsules. The capsules were administered orally, typically at a dose of 2-3 capsules (1g/capsule) every 3-5 minutes, totaling 40 capsules per dose for a total of 120 capsules. Treatment cycles were conducted every 3 weeks, with therapeutic efficacy assessed after every 2 cycles. Receives: Biological: Fecal microbiota transplantation (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and improvement rate of chemotherapy/targeted therapy-induced gastrointestinal symptoms in patients with gastrointestinal cancers
This outcome measure assesses the incidence (grade ≥1 per CTCAE 5.0) and improvement rate (≥1-grade reduction in symptom severity or ≥30% decrease in EORTC QLQ-C30 scores) of chemotherapy/targeted therapy-induced gastrointestinal (GI) symptoms (e.g., nausea, vomiting, diarrhea) in patients with gastrointestinal cancers receiving fecal microbiota transplantation (FMT), as determined by scale scores and adverse event grading at baseline and post-treatment follow-up.
Measured: At 8 weeks post-FMT
Secondary outcomes (3)
The incidence and improvement rate of gastrointestinal (GI) symptoms in patients with gastrointestinal cancers
This outcome measure assesses the incidence (grade ≥1 or exacerbation of baseline symptoms per CTCAE 5.0) and improvement rate (≥1-grade reduction in symptom severity or ≥30% decrease in GSRS scores) of chemotherapy/targeted therapy-induced gastrointestinal symptoms (e.g., nausea, vomiting) in patients with gastrointestinal cancers receiving FMT.
Measured: At 4 weeks post-FMT
Changes in Gut Microbiota Diversity Indices
This secondary outcome measure assesses changes in gut microbiota α-diversity (Shannon Index and Simpson Index, dimensionless, reflecting microbial richness and evenness) and β-diversity (Bray-Curtis dissimilarity and Jaccard distance, dimensionless, reflecting differences in community structure) after the 4th and 8th cycles of fecal microbiota transplantation (FMT) combined with chemotherapy/targeted therapy in patients with gastrointestinal cancers, using 16S rDNA high-throughput sequencing (V3-V4 region, Illumina NovaSeq platform) to evaluate FMT's regulatory effect on gut microbiota diversity during anti-tumor treatment.
Measured: At 4, 8 weeks post-FMT
Correlation Between Changes in Gut Microbiota Abundance and Improvement of Gastrointestinal Symptoms
This secondary outcome measure explores the correlation between dynamic changes in gut microbiota abundance (relative abundance % at phylum/genus/species levels; absolute abundance of key taxa, copies/μg fecal DNA, detected via 16S rDNA sequencing and qPCR) at baseline, 4th and 8th treatment cycles, and improvement of chemotherapy/targeted therapy-induced GI symptoms (≥30% GSRS score reduction or ≥1-grade CTCAE relief) in gastrointestinal cancer patients receiving FMT + anti-tumor treatment, using Spearman/Pearson coefficients and subgroup analyses by symptom type to reveal the underlying mechanism.
Measured: At 8 weeks post-FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Sep 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Microbiota Transplantation (FMT)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319364
- Sponsor's protocol ID
- 2025-1390
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 6 Jan 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Real-World Study Evaluating Fecal Microbiota Transplantation for the Prevention/Reduction of Chemotherapy/Targeted Therapy-Induced Gastrointestinal Symptoms in Patients With Gastrointestinal Cancers.
- ClinicalTrials.gov ID
- NCT07319364
- Acronym / sponsor ID
- 2025-1390
- Conditions
- Fecal Microbiota Transplantation (FMT), Gastrointestinal Neoplasms, Antineoplastic Agents, Drug-related Side Effects and Adverse Reactions
- Keywords
- Fecal Microbiota Transplantation, Gastrointestinal Neoplasms, Antineoplastic Agents, Drug-Related Side Effects and Adverse Reactions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 Jan 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.
The goal of this clinical trial is to learn if fecal microbiota transplantation can treat in Gastrointestinal cancer patients with chemotherapy / targeted gastrointestinal symptoms. The main question it aims to answer is: To evaluate the effect of fecal microbiota transplantation (FMT) on gastrointestinal tract in patients with gastrointestinal tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients in the control group continued their original chemotherapy/targeted therapy regimen, with each treatment cycle lasting 3 weeks, for a total of 5 cycles. Treatment efficacy was assessed after every 2 cycles. |
| Experimental Group | Experimental | Biological: Fecal microbiota transplantation (FMT)Patients in the FMT group received treatment starting from the fourth cycle on top of their existing regimen. They underwent one FMT treatment within 3 days prior to chemotherapy/targeted therapy during the fourth, sixth, and eighth cycles (weeks 3, 9, and 15 after study initiation). Each transplant consisted of approximately 40g of donor gut microbiota encapsulated in capsules. The capsules were administered orally, typically at a dose of 2-3 capsules (1g/capsule) every 3-5 minutes, totaling 40 capsules per dose for a total of 120 capsules. Treatment cycles were conducted every 3 weeks, with therapeutic efficacy assessed after every 2 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years, gender not restricted;
- Estimated survival time ≥ 3 months;
- Confirmed diagnosis of gastrointestinal tumors by pathological examination, including esophageal cancer, gastric cancer, colon cancer, rectal cancer, etc.;
- TNM staging of cancer in patients is Stage IV;
- Having undergone PD-1 or PD-L1 testing;
Key exclusion criteria (9 listed)
- Patients with major organ dysfunction or even failure, including but not limited to cardiac insufficiency or heart failure, renal insufficiency or renal failure, and hepatic insufficiency/hepatic failure;
- Uncontrolled or severe infections;
- Known history of psychotropic substance abuse, alcoholism, and drug abuse;
- Patients with severe infections complicated with septicemia or sepsis;
- Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules;
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 |
|---|---|---|
| Fecal microbiota transplantation (FMT)Also: Chemotherapy, Targeted TherapyBuilding upon the existing treatment regimen, starting from the fourth cycle, one FMT treatment was administered within 3 days prior to chemotherapy/targeted therapy during the fourth, sixth, and eighth cycles (weeks 3, 9, and 15 after study initiation). Each transplant consisted of approximately 40g of donor intestinal bacteria encapsulated in capsules. The capsules were administered orally, typically at a dose of 2-3 capsules (1g/capsule) every 3-5 minutes, totaling 40 capsules per dose for a total of 120 capsules. Treatment cycles were conducted every 3 weeks, with therapeutic efficacy assessed after every 2 cycles. | Biological | Experimental Group |
Primary outcome
Incidence and improvement rate of chemotherapy/targeted therapy-induced gastrointestinal symptoms in patients with gastrointestinal cancers
Time frame: At 8 weeks post-FMT
This outcome measure assesses the incidence (grade ≥1 per CTCAE 5.0) and improvement rate (≥1-grade reduction in symptom severity or ≥30% decrease in EORTC QLQ-C30 scores) of chemotherapy/targeted therapy-induced gastrointestinal (GI) symptoms (e.g., nausea, vomiting, diarrhea) in patients with gastrointestinal cancers receiving fecal microbiota transplantation (FMT), as determined by scale scores and adverse event grading at baseline and post-treatment follow-up.
3 secondary outcomes
The incidence and improvement rate of gastrointestinal (GI) symptoms in patients with gastrointestinal cancers
Time frame: At 4 weeks post-FMT
Changes in Gut Microbiota Diversity Indices
Time frame: At 4, 8 weeks post-FMT
Correlation Between Changes in Gut Microbiota Abundance and Improvement of Gastrointestinal Symptoms
Time frame: At 8 weeks post-FMT
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 6 Jan 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 1 study testing Fecal microbiota transplantation (FMT) in people with Fecal Microbiota Transplantation (FMT) and Gastrointestinal Neoplasms, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 13 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: looking for participants now, as of the sponsor's last update on 6 Jan 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Da Wang (86-0571-87784720, wangda0618@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and improvement rate of chemotherapy/targeted therapy-induced gastrointestinal symptoms in patients with gastrointestinal cancers (time frame: At 8 weeks post-FMT). 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 6 Jan 2026.