Study Purpose: This study aims to systematically analyze changes in the gut microbiota ofcolon polyp patients under different intervention models. It will evaluate the regulatoryeffects of modified Si-Ni-San on the composition, diversity, and potential functionalcharacteristics of the gut microbiota. Additionally, the study seeks to identify keymicrobiota 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 trialinvolving patients who have undergone colon polyp removal via colonoscopy. After resumingnormal oral diet, patients will be randomly assigned to either the Traditional ChineseMedicine (TCM) intervention group or the control group. The control group will receive acombination of glutamine and probiotics, while the TCM intervention group will receivemodified Si-Ni-San. Both groups will undergo a 4-week intervention period (with 4treatment cycles of 7 days each). Clinical symptoms will be assessed before and 1 weekafter the intervention using a Traditional Chinese Medicine symptom scale. Blood andstool samples will be collected to measure serum IL-6 and TNF-α levels, and 16S rRNA genesequencing will be performed on the stool microbiota. The study will compare changes inthe gut microbiota composition and diversity at different time points and between the twogroups. Differential microbiota will be identified through indicator species analysis andLEfSe, and effect sizes and 95% confidence intervals will be reported. Additionally, arandom forest model will be built, and ROC curves will be used to evaluate keydiscriminative bacterial genera. Exploratory analysis of microbiota phenotypes andpotential functions will be performed using BugBase and PICRUSt.
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.
Drug: TCM Intervention Group
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.
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
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.
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.
Xi 'an Hospital of Traditional Chinese Medicine
Xi'an, Shaanxi, China
Not Provided