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

NCT06561516 | Completed

• 1 other identifier: 3-2022-0046
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Improvement of gastrotintestinal symptoms

  4 months after surgery

• Improvement of bowel habits

  4 months after surgery

• Nutritional Indicators

  4 months after surgery

• Nutritional Indicators

  4 months after surgery

• Nutritional Indicator

  4 months after surgery

Study Arms (2)

Red ginseng group

EXPERIMENTAL

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)

Control group

NO INTERVENTION

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

Interventions

Arm I (Red ginseng) 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.

Red ginseng group

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients aged 80 years or older.
• Patients who received neoadjuvant therapy before surgery.
• 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).
• Patients unable to orally consume red ginseng tablets.
• Patients with a history of previous abdominal organ surgery, radiation therapy, or chemotherapy.
• Patients with intestinal obstruction before surgery.
• Patients regularly taking probiotic or prebiotic supplements.
• Patients requiring formation of an ileostomy after surgery.
• Patients with uncontrolled diabetes that may affect gastrointestinal function.
• Patients with underlying conditions such as liver failure or renal failure.
• Patients allergic to red ginseng.
• Patients who received more than two weeks of antibiotic treatment during hospitalization.

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severacne Hospital Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Colorectal Neoplasms

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The participating physicians in the study are kept unaware of which group each patient belongs to. However, patients are randomly divided into the Red ginseng and Control groups by research nurses, and they become aware of their group assignment (whether they will take red ginseng tablets or not) in a single-blind study format.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: We randomly assign enrolled patients in two groups, Red ginseng group and Control group. The Red ginseng group will consume red ginseng (ginsenoside 500mg/T) for three months starting one month after surgery. Microbiome analysis will be conducted before surgery and at four months after surgery to investigate the prebiotic effects of red ginseng on gut microbiota distribution. The control group will not recieve any intervention during the experimental periods.

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 20, 2024
• Study Start: June 14, 2022
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)