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

NCT ID: NCT06561516

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-14
• Study Completion Date: 2023-07-14

Brief 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

Stomach Cancer; Pancreatobiliary Cancer; Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Arm I (Red ginseng)

Intervention Type: PROCEDURE

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.

Control group

The control group will not receive any intervention during the experimental periods.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

In Gyu Kwon

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gangnam Severacne Hospital Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

3-2022-0046

Identifier Type: -

Identifier Source: org_study_id