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

Not Applicable

Completed

• Conditions: Colorectal Cancer; Stomach Cancer; Pancreatobiliary Cancer
• Interventions: Procedure: Arm I (Red ginseng)

• Registration Number: NCT06561516
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-14
• Primary Completion: 2023-07-14
• Study Completion: 2023-07-14
• Status Verified: 2024-08
• Study First Submitted: 2024-08-04
• Study First Submitted QC: 2024-08-19
• Last Update Submitted: 2024-08-19
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Red ginseng group	Arm I (Red ginseng)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gangnam Severacne Hospital Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of