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

Last updated: August 19, 2024
Sponsor: Gangnam Severance Hospital
Overall Status: Completed

Phase

N/A

Condition

Stomach Cancer

Gastric Cancer

Gastric Ulcers

Treatment

Arm I (Red ginseng)

Clinical Study ID

NCT06561516
3-2022-0046
  • Ages 19-79
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Pathologically diagnosed with gastrointestinal cancers (stomach cancer,pancreatobiliary cancer, colorectal cancer) prior to surgery.

  2. Clinically staged and anticipated to not receive adjuvant chemotherapy aftersurgery.

  3. Eligible for complete surgical resection (R0 resection).

  4. ASA (American Society of Anesthesiologists) score of 3 or below.

  5. Intereseted in health functional foods.

  6. Not consumed probiotics or prebiotics for at least three months prior to studyenrollment.

  7. Willing to refrain from consuming additional probiotics or prebiotics during thestudy period, apart from the provided red ginseng tablets.

Exclusion

Exclusion Criteria:

  1. Patients aged 80 years or older.

  2. Patients who received neoadjuvant therapy before surgery.

  3. Patients with underlying gastrointestinal disorders (e.g., inflammatory boweldisease, ulcerative colitis, Crohn's disease, galactose intolerance, lactasedeficiency, glucose-galactose malabsorption, short bowel syndrome, other hereditarygastrointestinal diseases, and autoimmune diseases).

  4. Patients unable to orally consume red ginseng tablets.

  5. Patients with a history of previous abdominal organ surgery, radiation therapy, orchemotherapy.

  6. Patients with intestinal obstruction before surgery.

  7. Patients regularly taking probiotic or prebiotic supplements.

  8. Patients requiring formation of an ileostomy after surgery.

  9. Patients with uncontrolled diabetes that may affect gastrointestinal function.

  10. Patients with underlying conditions such as liver failure or renal failure.

  11. Patients allergic to red ginseng.

  12. Patients who received more than two weeks of antibiotic treatment duringhospitalization.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Arm I (Red ginseng)
Phase:
Study Start date:
June 14, 2022
Estimated Completion Date:
July 14, 2023

Connect with a study center

  • Gangnam Severacne Hospital Yonsei University College of Medicine

    Seoul,
    Korea, Republic of

    Site Not Available

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