MedTrace Logo

Effects of Red Ginseng on Gastrointestinal Symptoms and Microbiota After Surgery for Gastrointestinal Cancer

NCT06561516 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-20

No results posted yet for this study

Summary

After surgery for gastrointestinal cancer (stomach cancer, pancreaticobiliary cancer, colorectal cancer), many patients experiences various symptoms such as weight loss, diarrhea, constipation and excessive gas due to structural and functional changes in the gastrointestinal tract. These changes are thought to be influenced by alterations in gut microbiota following surgery, but prospective studies are still lacking. It is anticipated that the prebiotic effects of red ginseng may lead to positive changes in total gut bactera after gastrointestinal caner surgery.

Through this study, Investigators aim to investigate the impact of red ginseng consumption on gut microbiota composition, gastrointestinal symptoms, and nutritional status improvement following surgery for gastrointestinal cancer.

Conditions

Interventions

PROCEDURE

Arm I (Red ginseng)

Step 1. Confrim the inclusion and exclusion criteria to select participants and abtain informed consent before surgery. Step 2. Before surgery, research nurses randomly assign patients to either the Red ginseng or Control group (single-blind study). Step 3. Blood tests and stool samples following rectal enema are collected from all patients before surgery. Step 4. Depending on the type of gastrointestinal cancer (stomach cancer, pancreatobiliary cancer, colorectal cancer), radical resection surgery is performed. Step 5. From 1 to 4 months after surgery, a three months period is designated for the Red ginseng group to take red ginseng tablets as instructed, with compliance assessements included. Step 6. Four months after surgery, blood tests and stool samples are collected from all patients. Step 7. After obtaining samples from the final registered patients, we will commission a contracted institution to conduct microbiome analysis test.

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2023-07-14
Completion
2023-07-14

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06561516 on ClinicalTrials.gov