Colorectal PolypsSNSNCT07442084
Efficacy of Modified Si Ni San in Post-Polypectomy Management and Its Impact on Gut Microbiota in Colorectal Polyp Patients
A study testing TCM Intervention Group in people with Colorectal Polyps and Modified SiNiSan, run by Xi'an Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
Study Purpose: This study aims to systematically analyze changes in the gut microbiota of colon polyp patients under different intervention models. It will evaluate the regulatory effects of modified Si-Ni-San on the composition, diversity, and potential functional characteristics of the gut microbiota. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Polyps, Modified SiNiSan
- What is being tested?
- TCM Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years;
- Diagnosed with colorectal polyps and underwent polypectomy via colonoscopy;
- Normal blood routine and liver/kidney function;
- Able to understand and sign informed consent.
Who cannot join
- History of colorectal cancer or a family history of colorectal polyps;
- Severe gastrointestinal diseases (e.g., inflammatory bowel disease, active infection);
- Pregnant or breastfeeding women;
- Severe comorbid conditions (e.g., diabetes, cardiovascular diseases) that may interfere with study results.
Trial locations and contacts
1 site in 1 country.
China1 site
Xi 'an Hospital of Traditional Chinese Medicine
Xi'an, Shaanxi, 710000
About this study
Study Purpose: This study aims to systematically analyze changes in the gut microbiota of colon polyp patients under different intervention models. It will evaluate the regulatory effects of modified Si-Ni-San on the composition, diversity, and potential functional characteristics of the gut microbiota. Additionally, the study seeks to identify key microbiota species associated with inflammation regulation and potential recurrence risk, providing theoretical support for microbiota-targeted intervention strategies.
Methods: This is a single-center, prospective, exploratory, randomized controlled trial involving patients who have undergone colon polyp removal via colonoscopy. After resuming normal oral diet, patients will be randomly assigned to either the Traditional Chinese Medicine (TCM) intervention group or the control group. The control group will receive a combination of glutamine and probiotics, while the TCM intervention group will receive modified Si-Ni-San. Both groups will undergo a 4-week intervention period (with 4 treatment cycles of 7 days each). Clinical symptoms will be assessed before and 1 week after the intervention using a Traditional Chinese Medicine symptom scale. Blood and stool samples will be collected to measure serum IL-6 and TNF-α levels, and 16S rRNA gene sequencing will be performed on the stool microbiota. The study will compare changes in the gut microbiota composition and diversity at different time points and between the two groups. Differential microbiota will be identified through indicator species analysis and LEfSe, and effect sizes and 95% confidence intervals will be reported. Additionally, a random forest model will be built, and ROC curves will be used to evaluate key discriminative bacterial genera. Exploratory analysis of microbiota phenotypes and potential functions will be performed using BugBase and PICRUSt.
Read the detailed description
Study Title Efficacy of Modified Si Ni San in Post-Polypectomy Management and Its Impact on Gut Microbiota in Colorectal Polyp Patients Study Type Interventional (Clinical Trial) Study Design Study Type: Single-center, prospective, exploratory randomized controlled trial Sample Size: 32 colorectal polyp patients Study Population: Patients who underwent polypectomy via colonoscopy Study Location: Xi'an Traditional Chinese Medicine Hospital, Xi'an, China Intervention Group: Modified Si Ni San (Chinese herbal treatment, 4 weeks) Control Group: Glutamine compound combined with probiotics (4 weeks) Intervention Time: Each intervention lasts for 4 weeks, 7 days per cycle, with 4 cycles in total Follow-up Time: Pre-treatment and 1 week post-treatment assessment Outcome Measures: Assessment of clinical symptoms, blood inflammatory cytokines (IL-6, TNF-α), and fecal microbiota using 16S rRNA sequencing.
Primary Objective To explore the therapeutic efficacy of Modified Si Ni San in regulating gut microbiota and its potential role in preventing post-polypectomy recurrence in colorectal polyp patients.
Secondary Objective To assess the impact of Modified Si Ni San on gut microbiota composition, community diversity, and functional characteristics, and to identify key microbiota associated with inflammation regulation and potential recurrence risk.
Research Hypothesis The investigators hypothesize that Modified Si Ni San, through its modulation of gut microbiota, can reduce the risk of recurrence in colorectal polyps post-surgery, with its mechanism involving the regulation of inflammatory responses and gut micro-ecosystem balance.
Study Methods
Intervention:
Herbal Intervention: The intervention group will receive Modified Si Ni San, consisting of specific Chinese herbs (e.g., Bupleurum, Paeonia, Tangerine Peel, etc.) prepared at Xi'an Traditional Chinese Medicine Hospital. The dosage is 1 dose per day, divided into two administrations (morning and evening) for 7 days per cycle. A total of 4 cycles will be administered, with a 2-day interval between each cycle.
Control Intervention: The control group will receive a combination of glutamine compound and probiotics, with the same duration and frequency of administration as the intervention group.
Outcome Assessment:
Symptom Evaluation: Using Traditional Chinese Medicine Symptom Quantification Table to evaluate clinical symptoms pre- and post-intervention.
Biological Sample Collection: Blood and fecal samples will be collected pre-treatment and 1 week post-treatment for analysis of inflammatory cytokines (IL-6, TNF-α) and gut microbiota (16S rRNA sequencing).
Statistical Methods:Comparison of microbiota composition at different time points and between groups.Indication species analysis and LEfSe to identify differential microbiota.Random Forest modeling and ROC curve to assess key discriminative microbiota.Exploratory analysis of microbiota phenotypes and potential functions using BugBase and PICRUSt.
Eligibility Criteria
Inclusion Criteria:
- Aged 18 to 70 years；
- Diagnosed with colorectal polyps and underwent polypectomy via colonoscopy;
- Normal blood routine and liver/kidney function;
- Able to understand and sign informed consent.
Exclusion Criteria:
- History of colorectal cancer or a family history of colorectal polyps;
- Severe gastrointestinal diseases (e.g., inflammatory bowel disease, active infection);
- Pregnant or breastfeeding women;
- Severe comorbid conditions (e.g., diabetes, cardiovascular diseases) that may interfere with study results.
Randomization and Allocation Random allocation will be performed using a pre-set random sequence, and the sequence generation and allocation concealment will be done by non-research staff to minimize bias.
Ethics and Informed Consent Ethics Approval: This study has been approved by the Ethics Committee of Xi'an Traditional Chinese Medicine Hospital (Approval Number: YJSLLSCP2025029).
Informed Consent: All participants will be provided with a detailed explanation of the study, including its purpose, procedures, potential risks, and benefits. Informed consent will be obtained from all participants prior to inclusion in the study.
Participant Recruitment Sample Size: 32 participants with colorectal polyps will be recruited. Reruitment Period: March 2025 to October 2025. Recruitment Status: Completed Recruitment Process: Participants were recruited from Xi'an Traditional Chinese Medicine Hospital, and those who met the inclusion criteria were invited to participate after being informed about the study and signing the informed consent.
- Conditions
- Colorectal Polyps, Modified SiNiSan
- Being tested
- TCM Intervention Group, Patients in this group will receive a combination of glutamine and probiotics for 4 weeks. This control intervention aims to compare the effects on gut microbiota composition and diversity
- Keywords
- Colorectal polyps, Modified SiNiSan (M-SNS);, Gut microbiota;Microbial diversity;, Microbiota-targeted intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM Intervention GroupDrug
The experimental intervention in this study is modified Si-Ni-San, a Traditional Chinese Medicine (TCM) formula, which is administered for 4 weeks. This intervention aims to regulate the gut microbiota composition and diversity in patients with colonic polyps. Unlike conventional therapies, Si-Ni-San is designed to modulate the gut microbiota with the potential to reduce inflammation and recurrence risks in patients post-polypectomy. The intervention is compared to the control group, which receives a combination of glutamine and probiotics.
Patients in this group will receive a combination of glutamine and probiotics for 4 weeks. This control intervention aims to compare the effects on gut microbiota composition and diversityDrug
The control group receives a combination of glutamine and probiotics for 4 weeks. Glutamine is an amino acid known for its role in supporting gut health, while probiotics are used to support the restoration and balance of gut microbiota. This intervention aims to serve as a baseline for comparison to the modified Si-Ni-San intervention in terms of gut microbiota composition, diversity, and potential functional changes in patients with colonic polyps.
| Study group | Role | What they receive |
|---|---|---|
| TCM Intervention Group (for the arm with Si-Ni-San intervention) | Experimental | For the TCM Intervention Group:Patients in this group will receive modified Si-Ni-San, a Traditional Chinese Medicine intervention, for 4 weeks. The intervention aims to regulate gut microbiota composition and diversity. Receives: Drug: TCM Intervention Group |
| Control Group | Active comparator | Patients in this group will receive a combination of glutamine and probiotics for 4 weeks. This control intervention aims to compare the effects on gut microbiota composition and diversity Receives: Drug: Patients in this group will receive a combination of glutamine and probiotics for 4 weeks. This control intervention aims to compare the effects on gut microbiota composition and diversity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiota Composition and Diversity
This outcome measures the changes in the composition and diversity of the gut microbiota before and after the 4-week intervention period in both the TCM and control groups. The investigators will analyze the differences using 16S rRNA sequencing data
Measured: Baseline, Week 4 (end of intervention), and 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start12 Mar 2025
- Primary completion1 Nov 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xi'an Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442084
- Sponsor's protocol ID
- YJSLLSCPJ2025029
- Other IDs
- 2023-135-01
- Acronym
- SNS
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the sensitive nature of the clinical data, particularly regarding patient health and privacy concerns, the investigators do not plan to share IPD with other researchers at this time. The data will be used solely for the purposes of this study and will remain confidential.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Modified Si Ni San in Post-Polypectomy Management and Its Impact on Gut Microbiota in Colorectal Polyp Patients
- ClinicalTrials.gov ID
- NCT07442084
- Acronym / sponsor ID
- SNS / YJSLLSCPJ2025029
- Conditions
- Colorectal Polyps, Modified SiNiSan
- Keywords
- Colorectal polyps, Modified SiNiSan (M-SNS);, Gut microbiota;Microbial diversity;, Microbiota-targeted intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Xi'an Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 2 Mar 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.
Study Purpose: This study aims to systematically analyze changes in the gut microbiota of colon polyp patients under different intervention models. It will evaluate the regulatory effects of modified Si-Ni-San on the composition, diversity, and potential functional characteristics of the gut microbiota. Additionally, the study seeks to identify key microbiota species associated with inflammation regulation and potential recurrence risk, providing theoretical support for microbiota-targeted intervention strategies.
Methods: This is a single-center, prospective, exploratory, randomized controlled trial involving patients who have undergone colon polyp removal via colonoscopy. After resuming normal oral diet, patients will be randomly assigned to either the Traditional Chinese Medicine (TCM) intervention group or the control group. The control group will receive a combination of glutamine and probiotics, while the TCM intervention group will receive modified Si-Ni-San. Both groups will undergo a 4-week intervention period (with 4 treatment cycles of 7 days each). Clinical symptoms will be assessed before and 1 week after the intervention using a Traditional Chinese Medicine symptom scale. Blood and stool samples will be collected to measure serum IL-6 and TNF-α levels, and 16S rRNA gene sequencing will be performed on the stool microbiota. The study will compare changes in the gut microbiota composition and diversity at different time points and between the two groups. Differential microbiota will be identified through indicator species analysis and LEfSe, and effect sizes and 95% confidence intervals will be reported. Additionally, a random forest model will be built, and ROC curves will be used to evaluate key discriminative bacterial genera. Exploratory analysis of microbiota phenotypes and potential functions will be performed using BugBase and PICRUSt.
Detailed description
Study Title Efficacy of Modified Si Ni San in Post-Polypectomy Management and Its Impact on Gut Microbiota in Colorectal Polyp Patients Study Type Interventional (Clinical Trial) Study Design Study Type: Single-center, prospective, exploratory randomized controlled trial Sample Size: 32 colorectal polyp patients Study Population: Patients who underwent polypectomy via colonoscopy Study Location: Xi'an Traditional Chinese Medicine Hospital, Xi'an, China Intervention Group: Modified Si Ni San (Chinese herbal treatment, 4 weeks) Control Group: Glutamine compound combined with probiotics (4 weeks) Intervention Time: Each intervention lasts for 4 weeks, 7 days per cycle, with 4 cycles in total Follow-up Time: Pre-treatment and 1 week post-treatment assessment Outcome Measures: Assessment of clinical symptoms, blood inflammatory cytokines (IL-6, TNF-α), and fecal microbiota using 16S rRNA sequencing.
Primary Objective To explore the therapeutic efficacy of Modified Si Ni San in regulating gut microbiota and its potential role in preventing post-polypectomy recurrence in colorectal polyp patients.
Secondary Objective To assess the impact of Modified Si Ni San on gut microbiota composition, community diversity, and functional characteristics, and to identify key microbiota associated with inflammation regulation and potential recurrence risk.
Research Hypothesis The investigators hypothesize that Modified Si Ni San, through its modulation of gut microbiota, can reduce the risk of recurrence in colorectal polyps post-surgery, with its mechanism involving the regulation of inflammatory responses and gut micro-ecosystem balance.
Study Methods
Intervention:
Herbal Intervention: The intervention group will receive Modified Si Ni San, consisting of specific Chinese herbs (e.g., Bupleurum, Paeonia, Tangerine Peel, etc.) prepared at Xi'an Traditional Chinese Medicine Hospital. The dosage is 1 dose per day, divided into two administrations (morning and evening) for 7 days per cycle. A total of 4 cycles will be administered, with a 2-day interval between each cycle.
Control Intervention: The control group will receive a combination of glutamine compound and probiotics, with the same duration and frequency of administration as the intervention group.
Outcome Assessment:
Symptom Evaluation: Using Traditional Chinese Medicine Symptom Quantification Table to evaluate clinical symptoms pre- and post-intervention.
Biological Sample Collection: Blood and fecal samples will be collected pre-treatment and 1 week post-treatment for analysis of inflammatory cytokines (IL-6, TNF-α) and gut microbiota (16S rRNA sequencing).
Statistical Methods:Comparison of microbiota composition at different time points and between groups.Indication species analysis and LEfSe to identify differential microbiota.Random Forest modeling and ROC curve to assess key discriminative microbiota.Exploratory analysis of microbiota phenotypes and potential functions using BugBase and PICRUSt.
Eligibility Criteria
Inclusion Criteria:
- Aged 18 to 70 years；
- Diagnosed with colorectal polyps and underwent polypectomy via colonoscopy;
- Normal blood routine and liver/kidney function;
- Able to understand and sign informed consent.
Exclusion Criteria:
- History of colorectal cancer or a family history of colorectal polyps;
- Severe gastrointestinal diseases (e.g., inflammatory bowel disease, active infection);
- Pregnant or breastfeeding women;
- Severe comorbid conditions (e.g., diabetes, cardiovascular diseases) that may interfere with study results.
Randomization and Allocation Random allocation will be performed using a pre-set random sequence, and the sequence generation and allocation concealment will be done by non-research staff to minimize bias.
Ethics and Informed Consent Ethics Approval: This study has been approved by the Ethics Committee of Xi'an Traditional Chinese Medicine Hospital (Approval Number: YJSLLSCP2025029).
Informed Consent: All participants will be provided with a detailed explanation of the study, including its purpose, procedures, potential risks, and benefits. Informed consent will be obtained from all participants prior to inclusion in the study.
Participant Recruitment Sample Size: 32 participants with colorectal polyps will be recruited. Reruitment Period: March 2025 to October 2025. Recruitment Status: Completed Recruitment Process: Participants were recruited from Xi'an Traditional Chinese Medicine Hospital, and those who met the inclusion criteria were invited to participate after being informed about the study and signing the informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM Intervention Group (for the arm with Si-Ni-San intervention) | Experimental | Drug: TCM Intervention GroupFor the TCM Intervention Group:Patients in this group will receive modified Si-Ni-San, a Traditional Chinese Medicine intervention, for 4 weeks. The intervention aims to regulate gut microbiota composition and diversity. |
| Control Group | Active comparator | Drug: Patients in this group will receive a combination of glutamine and probiotics for 4 weeks. This control intervention aims to compare the effects on gut microbiota composition and diversityPatients in this group will receive a combination of glutamine and probiotics for 4 weeks. This control intervention aims to compare the effects on gut microbiota composition and diversity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 to 70 years;
- Diagnosed with colorectal polyps and underwent polypectomy via colonoscopy;
- Normal blood routine and liver/kidney function;
- Able to understand and sign informed consent.
Key exclusion criteria (4 listed)
- History of colorectal cancer or a family history of colorectal polyps;
- Severe gastrointestinal diseases (e.g., inflammatory bowel disease, active infection);
- Pregnant or breastfeeding women;
- Severe comorbid conditions (e.g., diabetes, cardiovascular diseases) that may interfere with study results.
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 |
|---|---|---|
| TCM Intervention GroupThe experimental intervention in this study is modified Si-Ni-San, a Traditional Chinese Medicine (TCM) formula, which is administered for 4 weeks. This intervention aims to regulate the gut microbiota composition and diversity in patients with colonic polyps. Unlike conventional therapies, Si-Ni-San is designed to modulate the gut microbiota with the potential to reduce inflammation and recurrence risks in patients post-polypectomy. The intervention is compared to the control group, which receives a combination of glutamine and probiotics. | Drug | TCM Intervention Group (for the arm with Si-Ni-San intervention) |
| Patients in this group will receive a combination of glutamine and probiotics for 4 weeks. This control intervention aims to compare the effects on gut microbiota composition and diversityThe control group receives a combination of glutamine and probiotics for 4 weeks. Glutamine is an amino acid known for its role in supporting gut health, while probiotics are used to support the restoration and balance of gut microbiota. This intervention aims to serve as a baseline for comparison to the modified Si-Ni-San intervention in terms of gut microbiota composition, diversity, and potential functional changes in patients with colonic polyps. | Drug | Control Group |
Primary outcome
Gut Microbiota Composition and Diversity
Time frame: Baseline, Week 4 (end of intervention), and 1 week post-intervention
This outcome measures the changes in the composition and diversity of the gut microbiota before and after the 4-week intervention period in both the TCM and control groups. The investigators will analyze the differences using 16S rRNA sequencing data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to the sensitive nature of the clinical data, particularly regarding patient health and privacy concerns, the investigators do not plan to share IPD with other researchers at this time. The data will be used solely for the purposes of this study and will remain confidential.
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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 TCM Intervention Group in people with Colorectal Polyps and Modified SiNiSan, run by Xi'an Hospital of Traditional Chinese 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 2 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gut Microbiota Composition and Diversity (time frame: Baseline, Week 4 (end of intervention), and 1 week post-intervention). 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 2 Mar 2026.