Gangnam Severacne Hospital Yonsei University College of Medicine
Seoul, South Korea
NCT Number: NCT06561516
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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Notify Me19 year–79 year
All sexes
Interventional
Not applicable
Seoul, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 4 months after surgery
EORTC QLQ-30 questionaire: gas expulsion level and discomfort caused by gas expulsion)
Time frame: 4 months after surgery
Bowel habit questionnaire
Time frame: 4 months after surgery
Blood test- lymphocyte counts
Time frame: 4 months after surgery
Blood test- albumin level
Time frame: 4 months after surgery
Blood test- total protein level
Gangnam Severance Hospital
Other
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