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

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

Interventions

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.

Sponsors & Collaborators

• Xi'an Hospital of Traditional Chinese Medicine

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-12

Primary Completion

2025-11-01

Completion

2025-12-20

Countries

• China

Study Locations