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

Yonsei University Health System (YUHS)

Status: Completed

Conditions: Stomach Cancer; Pancreatobiliary Cancer; Colorectal Cancer

Treatments: Procedure: Arm I (Red ginseng)

Study type: Interventional

Funder types: Other

Identifiers

NCT06561516

3-2022-0046

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Red ginseng group

Experimental group

Description:

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.

Treatment:

Procedure: Arm I (Red ginseng)

Control group

No Intervention group

Description:

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