Efficacy of Modified Si Ni San in Post-Polypectomy Management and Its Impact on Gut Microbiota in Colorectal Polyp Patients

NCT07442084 | Completed

• 2 other identifiers: YJSLLSCPJ20250292023-135-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colorectal Polyps; Modified SiNiSan

Keywords

Colorectal polyps; Modified SiNiSan (M-SNS);; Gut microbiota;Microbial diversity;; Microbiota-targeted intervention

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, Week 4 (end of intervention), and 1 week post-intervention

Study Arms (2)

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.

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

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

Interventions

TCM Intervention Group DRUG

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.

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 diversity DRUG

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xi'an Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Xi 'an Hospital of Traditional Chinese Medicine

Xi'an, Shaanxi, 710000, China

Location

Related Links

• Related Info

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2026
• First Posted: March 2, 2026
• Study Start: March 12, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 20, 2025
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)