Pancreatic Cancer, ResectedFMT-TPNCT06960122
Clinical Study on Fecal Microbiota Transplantation for Diarrhea After Total Pancreatectomy
A study testing Fecal Microbiota Transplant (FMT) and Standard Therapy in people with Pancreatic Cancer, Resected and Diarrhea, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
By 2030, pancreatic cancer is projected to become the second leading cause of cancer-related deaths, with a 5-year survival rate below 10%. Approximately 20% of patients are diagnosed at a borderline resectable or resectable stage, and surgical resection remains the only curative option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Resected, Diarrhea
- What is being tested?
- Fecal Microbiota Transplant (FMT) and Standard Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 31 Dec 2028
- 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
- Age ≥18 years, regardless of gender.
- Anticipated survival ≥3 months.
- Severe post-total pancreatectomy diarrhea (as per HART score).
- Willing and able to provide written informed consent and complete follow-up assessments.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 1-3.
- No use of oral/intravenous broad-spectrum antibiotics within 3 days prior to enrollment.
- Ability to swallow capsules intact without chewing.
- Adequate organ function confirmed by screening-phase laboratory tests.
Who cannot join
- Major organ insufficiency/failure, including but not limited to:
- Cardiac insufficiency or heart failure Renal insufficiency or renal failure Hepatic insufficiency or liver failure
- Uncontrolled or severe infections.
- Documented history of:
- Psychoactive drug abuse Alcoholism Illicit drug use
- Severe infections complicated by sepsis or septicemia.
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- History of severe allergic reactions or known hypersensitivity to components of liquid live-bacterial enteric-coated capsules.
- Pregnancy or lactation, or women of childbearing potential refusing contraceptive measures during the 15-week observation period.
- Gastrointestinal perforation and/or fistulas.
- Other conditions deemed ineligible 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
Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang
Hangzhou, Zhejiang
Wen Cai
About this study
By 2030, pancreatic cancer is projected to become the second leading cause of cancer-related deaths, with a 5-year survival rate below 10%. Approximately 20% of patients are diagnosed at a borderline resectable or resectable stage, and surgical resection remains the only curative option. However, total pancreatectomy (TP) often leads to severe diarrhea (incidence rate: 43.5%) due to exocrine insufficiency, and current pancreatic enzyme replacement therapy shows limited efficacy in some patients.
Recent studies highlight the critical role of gut microbiota in pancreatic cancer progression and postoperative recovery. Patients with pancreatic ductal adenocarcinoma (PDAC) exhibit a 1000-fold increase in intrapancreatic bacterial load compared to normal tissues, with significantly elevated Bacteroides abundance and reduced Firmicutes and Proteobacteria in fecal samples. Postoperative dysbiosis is linked to complications; for example, diarrhea after cholecystectomy is dominated by Proteobacteria, suggesting that microbial imbalance may underlie diarrhea following TP.
To address this, the study proposes fecal microbiota transplantation (FMT) via oral capsules. FMT has proven effective in treating recurrent Clostridium difficile infection by restoring healthy microbiota. This research will systematically evaluate the efficacy and safety of FMT in alleviating post-TP diarrhea through clinical indicators and 16S rDNA sequencing, offering novel insights into postoperative management of pancreatic cancer.
- Conditions
- Pancreatic Cancer, Resected, Diarrhea
- Being tested
- Fecal Microbiota Transplant (FMT), Standard Therapy
- Medical subject headings
- Pancreatic Neoplasms, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplant (FMT)Procedure or surgery
One course of fecal microbiota transplantation (FMT) was administered in addition to standard therapy.
Standard TherapyOther
Standard Therapy Alone
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation | Experimental | One course of fecal microbiota transplantation (FMT) was administered in addition to standard therapy. Receives: Procedure: Fecal Microbiota Transplant (FMT) |
| Control | Active comparator | Standard Therapy Alone Receives: Other: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrhea HART Score
The Hart Diarrhea Scoring Scale assigns scores to nine categories. The total score is the sum of scores from each bowel movement on the same day, with each movement evaluated using this scale. A cumulative score of ≥12 points within 24 hours is classified as diarrhea.
Measured: Assessed every two cycles up to 24 weeks (each cycle is 21 days)
Secondary outcomes (4)
Gastrointestinal Symptom Rating Scale (GSRS)
The total score of the GSRS (Gastrointestinal Symptom Rating Scale) ranges from 0 to 78 points, with higher scores indicating more severe gastrointestinal symptoms in patients.
Measured: Assessed every two cycles up to 24 weeks (each cycle is 21 days)
Quality of Life (QoL) assessment
The maximum score is 60. A score of less than 20 indicates an extremely poor quality of life; 21-30, poor; 31-40, fair; 41-50, relatively good; and 51-60, good.
Measured: Assessed every two cycles up to 24 weeks (each cycle is 21 days)
Chemotherapy cycle delay rate
Measured: Assessed every two cycles up to 24 weeks (each cycle is 21 days)
Colonization status of intestinal beneficial flora
Stool samples were collected from patients at three time points: baseline, after 4 cycles of intervention, and after 8 cycles of intervention, for 16S rDNA sequencing.
Measured: At baseline, completion of 4 intervention cycles, and completion of 8 intervention cycles (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer, ResectedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, caiwen, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Wen Cai, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960122
- Sponsor's protocol ID
- 2025-0303
- Acronym
- FMT-TP
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 7 May 2025
- 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 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Fecal Microbiota Transplantation for Diarrhea After Total Pancreatectomy
- ClinicalTrials.gov ID
- NCT06960122
- Acronym / sponsor ID
- FMT-TP / 2025-0303
- Conditions
- Pancreatic Cancer, Resected, Diarrhea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 May 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.
By 2030, pancreatic cancer is projected to become the second leading cause of cancer-related deaths, with a 5-year survival rate below 10%. Approximately 20% of patients are diagnosed at a borderline resectable or resectable stage, and surgical resection remains the only curative option. However, total pancreatectomy (TP) often leads to severe diarrhea (incidence rate: 43.5%) due to exocrine insufficiency, and current pancreatic enzyme replacement therapy shows limited efficacy in some patients.
Recent studies highlight the critical role of gut microbiota in pancreatic cancer progression and postoperative recovery. Patients with pancreatic ductal adenocarcinoma (PDAC) exhibit a 1000-fold increase in intrapancreatic bacterial load compared to normal tissues, with significantly elevated Bacteroides abundance and reduced Firmicutes and Proteobacteria in fecal samples. Postoperative dysbiosis is linked to complications; for example, diarrhea after cholecystectomy is dominated by Proteobacteria, suggesting that microbial imbalance may underlie diarrhea following TP.
To address this, the study proposes fecal microbiota transplantation (FMT) via oral capsules. FMT has proven effective in treating recurrent Clostridium difficile infection by restoring healthy microbiota. This research will systematically evaluate the efficacy and safety of FMT in alleviating post-TP diarrhea through clinical indicators and 16S rDNA sequencing, offering novel insights into postoperative management of pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation | Experimental | Procedure: Fecal Microbiota Transplant (FMT)One course of fecal microbiota transplantation (FMT) was administered in addition to standard therapy. |
| Control | Active comparator | Other: Standard TherapyStandard Therapy Alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years, regardless of gender.
- Anticipated survival ≥3 months.
- Severe post-total pancreatectomy diarrhea (as per HART score).
- Willing and able to provide written informed consent and complete follow-up assessments.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 1-3.
Key exclusion criteria (10 listed)
- Major organ insufficiency/failure, including but not limited to:
- Cardiac insufficiency or heart failure Renal insufficiency or renal failure Hepatic insufficiency or liver failure
- Uncontrolled or severe infections.
- Documented history of:
- Psychoactive drug abuse Alcoholism Illicit drug use
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 Transplant (FMT)One course of fecal microbiota transplantation (FMT) was administered in addition to standard therapy. | Procedure or surgery | Fecal microbiota transplantation |
| Standard TherapyStandard Therapy Alone | Other | Control |
Primary outcome
Diarrhea HART Score
Time frame: Assessed every two cycles up to 24 weeks (each cycle is 21 days)
The Hart Diarrhea Scoring Scale assigns scores to nine categories. The total score is the sum of scores from each bowel movement on the same day, with each movement evaluated using this scale. A cumulative score of ≥12 points within 24 hours is classified as diarrhea.
4 secondary outcomes
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Assessed every two cycles up to 24 weeks (each cycle is 21 days)
Quality of Life (QoL) assessment
Time frame: Assessed every two cycles up to 24 weeks (each cycle is 21 days)
Chemotherapy cycle delay rate
Time frame: Assessed every two cycles up to 24 weeks (each cycle is 21 days)
Colonization status of intestinal beneficial flora
Time frame: At baseline, completion of 4 intervention cycles, and completion of 8 intervention cycles (each cycle is 21 days)
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 7 May 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.
Wen Cai principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplant (FMT) and Standard Therapy in people with Pancreatic Cancer, Resected and Diarrhea, 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 8 inclusion and 10 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 7 May 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diarrhea HART Score (time frame: Assessed every two cycles up to 24 weeks (each cycle is 21 days)). 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 7 May 2025.