Rectal CancerNCT07711509
Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Rectal Cancer
A study testing Autologous Fecal Microbiota Transplantation in people with Rectal Cancer and Low Anterior Resection Syndrome, run by Peking University People's Hospital at 1 site in China.
Trial summary
This prospective, single-center, single-arm, open-label clinical study aims to evaluate whether autologous fecal microbiota transplantation can improve bowel and anal function after ileostomy reversal in patients with rectal cancer who underwent radical rectal cancer surgery with protective loop ileostomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Low Anterior Resection Syndrome, Fecal Incontinence
- What is being tested?
- Autologous Fecal Microbiota Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2025to 1 Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years.
- Histologically or clinically confirmed rectal cancer with the lower tumor margin less than 12 cm from the anal verge.
- Undergoing radical rectal cancer surgery with protective loop ileostomy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Able to understand the study procedures and willing to provide written informed consent.
Who cannot join
- History of inflammatory bowel disease, bacterial colitis, or other preoperative colonic inflammatory disease.
- Requirement for emergency surgery due to intestinal obstruction, perforation, bleeding, or other emergency conditions.
- Pregnant or lactating women.
- Presence of clinically significant gut microbiota dysbiosis before enrollment, as judged by the investigator.
- Planned postoperative radiotherapy, chemotherapy, or chemoradiotherapy.
- Poor compliance, inability to tolerate the intervention, or judged by the investigator to be unsuitable for participation in this clinical study.
- Severe postoperative complications such as anastomotic leakage.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Patients With Rectal Cancer: A Prospective, Single-center, Single-arm, Open-label Clinical Study
This prospective, single-center, single-arm, open-label clinical study aims to evaluate whether autologous fecal microbiota transplantation can improve bowel and anal function after ileostomy reversal in patients with rectal cancer who underwent radical rectal cancer surgery with protective loop ileostomy. Eligible patients will receive autologous fecal microbiota transplantation before ileostomy reversal. The primary outcome is the Low Anterior Resection Syndrome score at 3 months after ileostomy reversal. Secondary outcomes include fecal incontinence score, colonoscopic findings before ileostomy reversal, gut microbiota profiles, inflammatory markers, anorectal manometry, pelvic floor electromyography, and safety outcomes.
Read the detailed description
Patients with rectal cancer who undergo radical resection with protective loop ileostomy may experience diversion-related changes in the distal bowel, gut microbiota dysbiosis, diversion colitis, and impaired bowel function after ileostomy reversal. Autologous fecal microbiota transplantation may help restore the intestinal microbial environment in the defunctioned bowel and improve postoperative bowel function.
In this study, eligible patients will undergo standard radical rectal cancer surgery with protective loop ileostomy. At approximately 8 weeks after surgery, patients without severe postoperative complications such as anastomotic leakage will undergo anal swab sampling for 16S rRNA gene sequencing. Autologous fecal microbiota transplantation will be performed once weekly at postoperative weeks 8, 9, 10, and 11. At approximately 12 weeks after surgery, colonoscopy will be performed to evaluate the distal bowel mucosa, and intestinal secretion samples will be collected for 16S rRNA gene sequencing. Ileostomy reversal will then be performed according to routine clinical practice. Bowel function will be followed for 3 months after ileostomy reversal, with the primary endpoint being the LARS score at 3 months after reversal.
- Conditions
- Rectal Cancer, Low Anterior Resection Syndrome, Fecal Incontinence, Diversion Colitis, Ileostomy, Gut Microbiota Dysbiosis
- Being tested
- Autologous Fecal Microbiota Transplantation
- Keywords
- autologous fecal microbiota transplantation, rectal cancer, ileostomy reversal, low anterior resection syndrome, LARS score, diversion colitis, gut microbiota, 16S rRNA sequencing, anal function, bowel function
- Medical subject headings
- Rectal Neoplasms, Low Anterior Resection Syndrome, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Fecal Microbiota TransplantationBiological
Autologous fecal microbiota transplantation will be prepared from the participant's own fecal material collected from the ileostomy output. Approximately 50 g of fecal material will be mixed with 100 mL sterile normal saline, homogenized, filtered through sterile sieves, and administered slowly into the distal bowel via transanal catheter/enema. The procedure will be performed once weekly at postoperative weeks 8, 9, 10, and 11, for a total of four administrations. Participants will be observed after the procedure according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Fecal Microbiota Transplantation Group | Experimental | Participants with rectal cancer who underwent radical rectal cancer surgery with protective loop ileostomy will receive autologous fecal microbiota transplantation before ileostomy reversal. Receives: Biological: Autologous Fecal Microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Anterior Resection Syndrome Score at 3 Months After Ileostomy Reversal
Low Anterior Resection Syndrome (LARS) score will be assessed using the LARS questionnaire at 3 months after ileostomy reversal. The total score ranges from 0 to 42 points, with higher scores indicating more severe bowel dysfunction. Scores of 0-20 indicate no LARS, 21-29 indicate minor LARS, and 30-42 indicate major LARS.
Measured: 3 months after ileostomy reversal
Secondary outcomes (1)
Colonoscopic Mucosal Findings Before Ileostomy Reversal
The distal bowel mucosa will be evaluated by colonoscopy before ileostomy reversal. Findings related to diversion colitis, including mucosal erythema, edema, friability, erosion, ulceration, bleeding, and mucus retention, will be recorded.
Measured: Approximately 12 weeks after initial surgery and before ileostomy reversal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start25 Mar 2025
- Primary completion20 May 2026
- 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 Rectal CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Zhanlong, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711509
- Sponsor's protocol ID
- PKUPH-FMT-01
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The study is a single-center clinical study with a relatively small sample size and includes sensitive clinical information, surgical details, functional outcomes, and microbiome sequencing data. Even after de-identification, there may remain a potential risk of participant re-identification. In addition, the informed consent form did not include specific permission for public sharing of individual-level participant data. Aggregate study results will be reported in publications or presentations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Patients With Rectal Cancer: A Prospective, Single-center, Single-arm, Open-label Clinical Study
- ClinicalTrials.gov ID
- NCT07711509
- Acronym / sponsor ID
- PKUPH-FMT-01
- Conditions
- Rectal Cancer, Low Anterior Resection Syndrome, Fecal Incontinence, Diversion Colitis, Ileostomy, Gut Microbiota Dysbiosis
- Keywords
- autologous fecal microbiota transplantation, rectal cancer, ileostomy reversal, low anterior resection syndrome, LARS score, diversion colitis, gut microbiota, 16S rRNA sequencing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 17 Jul 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.
This prospective, single-center, single-arm, open-label clinical study aims to evaluate whether autologous fecal microbiota transplantation can improve bowel and anal function after ileostomy reversal in patients with rectal cancer who underwent radical rectal cancer surgery with protective loop ileostomy. Eligible patients will receive autologous fecal microbiota transplantation before ileostomy reversal. The primary outcome is the Low Anterior Resection Syndrome score at 3 months after ileostomy reversal. Secondary outcomes include fecal incontinence score, colonoscopic findings before ileostomy reversal, gut microbiota profiles, inflammatory markers, anorectal manometry, pelvic floor electromyography, and safety outcomes.
Detailed description
Patients with rectal cancer who undergo radical resection with protective loop ileostomy may experience diversion-related changes in the distal bowel, gut microbiota dysbiosis, diversion colitis, and impaired bowel function after ileostomy reversal. Autologous fecal microbiota transplantation may help restore the intestinal microbial environment in the defunctioned bowel and improve postoperative bowel function.
In this study, eligible patients will undergo standard radical rectal cancer surgery with protective loop ileostomy. At approximately 8 weeks after surgery, patients without severe postoperative complications such as anastomotic leakage will undergo anal swab sampling for 16S rRNA gene sequencing. Autologous fecal microbiota transplantation will be performed once weekly at postoperative weeks 8, 9, 10, and 11. At approximately 12 weeks after surgery, colonoscopy will be performed to evaluate the distal bowel mucosa, and intestinal secretion samples will be collected for 16S rRNA gene sequencing. Ileostomy reversal will then be performed according to routine clinical practice. Bowel function will be followed for 3 months after ileostomy reversal, with the primary endpoint being the LARS score at 3 months after reversal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Fecal Microbiota Transplantation Group | Experimental | Biological: Autologous Fecal Microbiota TransplantationParticipants with rectal cancer who underwent radical rectal cancer surgery with protective loop ileostomy will receive autologous fecal microbiota transplantation before ileostomy reversal. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 75 years.
- Histologically or clinically confirmed rectal cancer with the lower tumor margin less than 12 cm from the anal verge.
- Undergoing radical rectal cancer surgery with protective loop ileostomy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Able to understand the study procedures and willing to provide written informed consent.
Key exclusion criteria (7 listed)
- History of inflammatory bowel disease, bacterial colitis, or other preoperative colonic inflammatory disease.
- Requirement for emergency surgery due to intestinal obstruction, perforation, bleeding, or other emergency conditions.
- Pregnant or lactating women.
- Presence of clinically significant gut microbiota dysbiosis before enrollment, as judged by the investigator.
- Planned postoperative radiotherapy, chemotherapy, or chemoradiotherapy.
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 |
|---|---|---|
| Autologous Fecal Microbiota TransplantationAutologous fecal microbiota transplantation will be prepared from the participant's own fecal material collected from the ileostomy output. Approximately 50 g of fecal material will be mixed with 100 mL sterile normal saline, homogenized, filtered through sterile sieves, and administered slowly into the distal bowel via transanal catheter/enema. The procedure will be performed once weekly at postoperative weeks 8, 9, 10, and 11, for a total of four administrations. Participants will be observed after the procedure according to the study protocol. | Biological | Autologous Fecal Microbiota Transplantation Group |
Primary outcome
Low Anterior Resection Syndrome Score at 3 Months After Ileostomy Reversal
Time frame: 3 months after ileostomy reversal
Low Anterior Resection Syndrome (LARS) score will be assessed using the LARS questionnaire at 3 months after ileostomy reversal. The total score ranges from 0 to 42 points, with higher scores indicating more severe bowel dysfunction. Scores of 0-20 indicate no LARS, 21-29 indicate minor LARS, and 30-42 indicate major LARS.
1 secondary outcome
Colonoscopic Mucosal Findings Before Ileostomy Reversal
Time frame: Approximately 12 weeks after initial surgery and before ileostomy reversal
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 17 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The study is a single-center clinical study with a relatively small sample size and includes sensitive clinical information, surgical details, functional outcomes, and microbiome sequencing data. Even after de-identification, there may remain a potential risk of participant re-identification. In addition, the informed consent form did not include specific permission for public sharing of individual-level participant data. Aggregate study results will be reported in publications or presentations.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Fecal Microbiota Transplantation in people with Rectal Cancer and Low Anterior Resection Syndrome, run by Peking University People's Hospital 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 7 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 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.
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?
Low Anterior Resection Syndrome Score at 3 Months After Ileostomy Reversal (time frame: 3 months after ileostomy reversal). 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 17 Jul 2026.