Stomach CancerNCT06561516
Effects of Red Ginseng on Gastrointestinal Symptoms and Microbiota After Surgery for Gastrointestinal Cancer
A study testing Arm I (Red ginseng) in people with Stomach Cancer and Pancreatobiliary Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Stomach Cancer, Pancreatobiliary Cancer, Colorectal Cancer
- What is being tested?
- Arm I (Red ginseng)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jun 2022to 14 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gangnam Severacne Hospital Yonsei University College of Medicine
Seoul
About this study
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
- Being tested
- Arm I (Red ginseng)
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm I (Red ginseng)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Arm I (Red ginseng) |
| Control group | No intervention | The control group will not receive any intervention during the experimental periods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months after surgery
Secondary outcomes (5)
Improvement of gastrotintestinal symptoms
EORTC QLQ-30 questionaire: gas expulsion level and discomfort caused by gas expulsion)
Measured: 4 months after surgery
Improvement of bowel habits
Bowel habit questionnaire
Measured: 4 months after surgery
Nutritional Indicators
Blood test- lymphocyte counts
Measured: 4 months after surgery
Nutritional Indicators
Blood test- albumin level
Measured: 4 months after surgery
Nutritional Indicator
Blood test- total protein level
Measured: 4 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start14 Jun 2022
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Gyu Kwon, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561516
- Sponsor's protocol ID
- 3-2022-0046
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Red Ginseng on Gastrointestinal Symptoms and Microbiota After Surgery for Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT06561516
- Acronym / sponsor ID
- 3-2022-0046
- Conditions
- Stomach Cancer, Pancreatobiliary Cancer, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Red ginseng group | Experimental | Procedure: 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. |
| Control group | No intervention | –The control group will not receive any intervention during the experimental periods. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm I (Red ginseng)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. | Procedure or surgery | Red ginseng group |
Primary outcome
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.
5 secondary outcomes
Improvement of gastrotintestinal symptoms
Time frame: 4 months after surgery
Improvement of bowel habits
Time frame: 4 months after surgery
Nutritional Indicators
Time frame: 4 months after surgery
Nutritional Indicators
Time frame: 4 months after surgery
Nutritional Indicator
Time frame: 4 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm I (Red ginseng) in people with Stomach Cancer and Pancreatobiliary Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in microbiome composition based on the consumption or non-consumption of red ginseng following gastrointestinal cancer surgery. (time frame: 4 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.