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Completed

NCT Number: NCT06561516

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.

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Key information

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam Severacne Hospital Yonsei University College of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Changes in microbiome composition based on the consumption or non-consumption of red ginseng following gastrointestinal cancer surgery.

    Time frame: 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 outcomes

  1. Improvement of gastrotintestinal symptoms

    Time frame: 4 months after surgery

    EORTC QLQ-30 questionaire: gas expulsion level and discomfort caused by gas expulsion)

  2. Improvement of bowel habits

    Time frame: 4 months after surgery

    Bowel habit questionnaire

  3. Nutritional Indicators

    Time frame: 4 months after surgery

    Blood test- lymphocyte counts

  4. Nutritional Indicators

    Time frame: 4 months after surgery

    Blood test- albumin level

  5. Nutritional Indicator

    Time frame: 4 months after surgery

    Blood test- total protein level

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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