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

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.

Study Overview

• Status: Completed
• Conditions: Stomach Cancer; Colorectal Cancer; Pancreatobiliary Cancer
• Intervention / Treatment: Procedure: Arm I (Red ginseng)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severacne Hospital Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Pathologically diagnosed with gastrointestinal cancers (stomach cancer, pancreatobiliary cancer, colorectal cancer) prior to surgery.
2. Clinically staged and anticipated to not receive adjuvant chemotherapy after surgery.
3. Eligible for complete surgical resection (R0 resection).
4. ASA (American Society of Anesthesiologists) score of 3 or below.
5. Intereseted in health functional foods.
6. Not consumed probiotics or prebiotics for at least three months prior to study enrollment.
7. Willing to refrain from consuming additional probiotics or prebiotics during the study period, apart from the provided red ginseng tablets.

Exclusion Criteria:

1. Patients aged 80 years or older.
2. Patients who received neoadjuvant therapy before surgery.
3. Patients with underlying gastrointestinal disorders (e.g., inflammatory bowel disease, ulcerative colitis, Crohn's disease, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, short bowel syndrome, other hereditary gastrointestinal diseases, and autoimmune diseases).
4. Patients unable to orally consume red ginseng tablets.
5. Patients with a history of previous abdominal organ surgery, radiation therapy, or chemotherapy.
6. Patients with intestinal obstruction before surgery.
7. Patients regularly taking probiotic or prebiotic supplements.
8. Patients requiring formation of an ileostomy after surgery.
9. Patients with uncontrolled diabetes that may affect gastrointestinal function.
10. Patients with underlying conditions such as liver failure or renal failure.
11. Patients allergic to red ginseng.
12. Patients who received more than two weeks of antibiotic treatment during hospitalization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Red ginseng group; The Red ginseng group will consume red ginseng (ginsenoside 500mg/T) for three months starting one month after surgery. Patients take 2 tablets of 500mg ginsenoside twice daily.	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.
No Intervention: Control group; The control group will not receive any intervention during the experimental periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in microbiome composition based on the consumption or non-consumption of red ginseng following gastrointestinal cancer surgery.	We observe changes in total gut bacteria following gastrointestinal cancer surgery based on the consumption of red ginseng through analysis of fecal microbiome.	4 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of gastrotintestinal symptoms	EORTC QLQ-30 questionaire: gas expulsion level and discomfort caused by gas expulsion)	4 months after surgery
Improvement of bowel habits	Bowel habit questionnaire	4 months after surgery
Nutritional Indicators	Blood test- lymphocyte counts	4 months after surgery
Nutritional Indicators	Blood test- albumin level	4 months after surgery
Nutritional Indicator	Blood test- total protein level	4 months after surgery

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Actual): July 14, 2023
• Study Completion (Actual): July 14, 2023

Study Registration Dates

• First Submitted: August 4, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Gastrointestinal Neoplasms
• Other Study ID Numbers: 3-2022-0046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No