Low Anterior Resection SyndromeFMT-LARSNCT06475430
Fecal Microbiota Transplantation in the Treatment of Major LARS
A study testing fecal microbiota transplantation and Formulated probiotic supplements in people with Low Anterior Resection Syndrome and Fecal Microbiota Transplantation, run by Peking University People's Hospital.
Trial summary
Randomized trial to assess FMT efficacy in improving bowel function for major LARS patients. 40 subjects, blinded, randomized to FMT or probiotics. Pre-post 16S sequencing, 4-week follow-up for bowel symptoms, 8-week microbiota analysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Anterior Resection Syndrome, Fecal Microbiota Transplantation
- What is being tested?
- fecal microbiota transplantation and Formulated probiotic supplements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, regardless of gender; Patients with rectal cancer who have undergone total mesorectal excision (TME) and sphincter-preserving surgery, and the postoperative period is more than 3 months; Patients with a LARS score of 21 to 42; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Expected survival period ≥ 1 year; Voluntarily sign a written informed consent form.
Who cannot join
- Patients with pre-operative symptoms of fecal and urinary incontinence; Patients who have undergone pelvic surgery or LAR due to non-cancerous reasons; Patients who have undergone pelvic radiotherapy; Patients with prophylactic ostomy; Patients who have used any antibiotic medication, probiotic products, or prebiotic products in the past 4 weeks; Patients who have regularly used laxatives in the past two weeks; Pregnant or lactating women; Human immunodeficiency virus (HIV) positive; Known history of active pulmonary tuberculosis (TB). Subjects suspected of having active TB require chest X-ray, sputum examination, and exclusion based on clinical symptoms and signs; Untreated patients with chronic hepatitis B or HBV carriers with HBV DNA exceeding 500 IU/mL, or patients with active hepatitis C should be excluded. Non-active HBsAg carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL), and cured hepatitis C patients can be enrolled. For subjects with positive HCV antibodies, only those with negative HCV RNA test results are eligible to participate in the study; Known history of psychiatric drug abuse, alcoholism, and drug abuse; Patients with cognitive impairment; Any situation where the investigator believes the participant should be excluded from the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Effectiveness of Fecal Microbiota Transplantation in the Treatment of Patients With Severe Low Anterior Resection Syndrome (LARS)
Randomized trial to assess FMT efficacy in improving bowel function for major LARS patients. 40 subjects, blinded, randomized to FMT or probiotics. Pre-post 16S sequencing, 4-week follow-up for bowel symptoms, 8-week microbiota analysis.
Read the detailed description
This study is a rigorous single-center, prospective, double-blinded, randomized controlled trial, aiming to evaluate the effectiveness of fecal microbiota transplantation (FMT) in improving bowel function for patients with major low anterior resection syndrome (LARS). A total of 40 subjects are planned to be recruited and randomly assigned to the experimental group and the control group at a 1:1 ratio. Prior to treatment, all subjects will undergo 16S sequencing of intestinal microbiota to assess their intestinal microecological status. During the treatment, a colonoscopic colonic catheter will be placed via the anus, with the experimental group receiving FMT solution matched to the patient's microbiota for intra-intestinal administration, while the control group will receive a standardized probiotic formula. To ensure the impartiality of the study, both patients and researchers administering the medication will be blinded to the trial drugs. The study will continuously observe and record bowel symptoms after 4 weeks of treatment as well as 16S sequencing results of intestinal microbiota after 8 weeks. Upon the completion of the entire study, the blinding will be revealed, and the results will be analyzed.
- Being tested
- fecal microbiota transplantation, Formulated probiotic supplements
- Keywords
- low anterior resection syndrome, bowel function, fecal microbiota transplantation, intestinal microbiota
- Medical subject headings
- Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal microbiota transplantationBiological
Also called FMT
During the treatment, a colonoscopic colonic catheter will be placed via the anus, with the experimental group receiving FMT solution matched to the patient's microbiota for intra-intestinal administration.
Formulated probiotic supplementsDietary supplement
Also called probiotic
During the treatment, a colonoscopic colonic catheter will be placed via the anus, with the control group receiving a standardized probiotic formula.
| Study group | Role | What they receive |
|---|---|---|
| Fecal flora transplantation group | Experimental | Not described Receives: Biological: fecal microbiota transplantation |
| Formulated probiotics group | Active comparator | Not described Receives: Dietary Supplement: Formulated probiotic supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
bowel function
LARS score
Measured: 4 weeks and 8 weeks
Shannon index
biodiversity monitoring
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Anterior Resection SyndromeStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Liu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475430
- Sponsor's protocol ID
- BaS-2406
- Acronym
- FMT-LARS
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 26 Jun 2024
- 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Fecal Microbiota Transplantation in the Treatment of Patients With Severe Low Anterior Resection Syndrome (LARS)
- ClinicalTrials.gov ID
- NCT06475430
- Acronym / sponsor ID
- FMT-LARS / BaS-2406
- Keywords
- low anterior resection syndrome, bowel function, fecal microbiota transplantation, intestinal microbiota
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jun 2024 (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.
Randomized trial to assess FMT efficacy in improving bowel function for major LARS patients. 40 subjects, blinded, randomized to FMT or probiotics. Pre-post 16S sequencing, 4-week follow-up for bowel symptoms, 8-week microbiota analysis.
Detailed description
This study is a rigorous single-center, prospective, double-blinded, randomized controlled trial, aiming to evaluate the effectiveness of fecal microbiota transplantation (FMT) in improving bowel function for patients with major low anterior resection syndrome (LARS). A total of 40 subjects are planned to be recruited and randomly assigned to the experimental group and the control group at a 1:1 ratio. Prior to treatment, all subjects will undergo 16S sequencing of intestinal microbiota to assess their intestinal microecological status. During the treatment, a colonoscopic colonic catheter will be placed via the anus, with the experimental group receiving FMT solution matched to the patient's microbiota for intra-intestinal administration, while the control group will receive a standardized probiotic formula. To ensure the impartiality of the study, both patients and researchers administering the medication will be blinded to the trial drugs. The study will continuously observe and record bowel symptoms after 4 weeks of treatment as well as 16S sequencing results of intestinal microbiota after 8 weeks. Upon the completion of the entire study, the blinding will be revealed, and the results will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal flora transplantation group | Experimental | Biological: fecal microbiota transplantation |
| Formulated probiotics group | Active comparator | Dietary Supplement: Formulated probiotic supplements |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 18 years old, regardless of gender; Patients with rectal cancer who have undergone total mesorectal excision (TME) and sphincter-preserving surgery, and the postoperative period is more than 3 months; Patients with a LARS score of 21 to 42; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Expected survival period ≥ 1 year; Voluntarily sign a written informed consent form.
Key exclusion criteria (1 listed)
- Patients with pre-operative symptoms of fecal and urinary incontinence; Patients who have undergone pelvic surgery or LAR due to non-cancerous reasons; Patients who have undergone pelvic radiotherapy; Patients with prophylactic ostomy; Patients who have used any antibiotic medication, probiotic products, or prebiotic products in the past 4 weeks; Patients who have regularly used laxatives in the past two weeks; Pregnant or lactating women; Human immunodeficiency virus (HIV) positive; Known history of active pulmonary tuberculosis (TB). Subjects suspected of having active TB require chest X-ray, sputum examination, and exclusion based on clinical symptoms and signs; Untreated patients with chronic hepatitis B or HBV carriers with HBV DNA exceeding 500 IU/mL, or patients with active hepatitis C should be excluded. Non-active HBsAg carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL), and cured hepatitis C patients can be enrolled. For subjects with positive HCV antibodies, only those with negative HCV RNA test results are eligible to participate in the study; Known history of psychiatric drug abuse, alcoholism, and drug abuse; Patients with cognitive impairment; Any situation where the investigator believes the participant should be excluded from the study.
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 transplantationAlso: FMTDuring the treatment, a colonoscopic colonic catheter will be placed via the anus, with the experimental group receiving FMT solution matched to the patient's microbiota for intra-intestinal administration. | Biological | Fecal flora transplantation group |
| Formulated probiotic supplementsAlso: probioticDuring the treatment, a colonoscopic colonic catheter will be placed via the anus, with the control group receiving a standardized probiotic formula. | Dietary supplement | Formulated probiotics group |
Primary outcome
bowel function
Time frame: 4 weeks and 8 weeks
LARS score
Shannon index
Time frame: 8 weeks
biodiversity monitoring
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 26 Jun 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing fecal microbiota transplantation and Formulated probiotic supplements in people with Low Anterior Resection Syndrome and Fecal Microbiota Transplantation, run by Peking University People's Hospital.
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 1 inclusion and 1 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 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Fan Liu, Doctor (01088326600, liufan92@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bowel function (time frame: 4 weeks and 8 weeks). The study lists 2 primary outcomes in all. 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 26 Jun 2024.