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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control group | No Intervention | The control group will not receive any intervention during the experimental periods. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of gastrotintestinal symptoms | EORTC QLQ-30 questionaire: gas expulsion level and discomfort caused by gas expulsion) | 4 months after surgery |
| Improvement of bowel habits | Bowel habit questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severacne Hospital Yonsei University College of Medicine | Seoul | South Korea |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
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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.
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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.
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| 4 months after surgery |
| Nutritional Indicators | Blood test- lymphocyte counts | 4 months after surgery |
| Nutritional Indicators | Blood test- albumin level | 4 months after surgery |
| Nutritional Indicator | Blood test- total protein level | 4 months after surgery |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |