UMIN ID: UMIN000002343
Registered date:17/08/2009
Randomized phase II clinical study on preventive effects of GPS, healthy food on the incidence of infection cases in stomach and colon cancer patients before and after the abdominal surgery
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | stomach and colon cancer patients |
| Date of first enrollment | 2009/06/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | GPS group 250mg of GPS (a cupsel contain 125mg of GPS) are orally taken continuously for 3 days before operation and for 27days after opperation. |
Outcome(s)
| Primary Outcome | incidence of Surgical Site Infection |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Sevier compromised patient(more than PS3) 2. Patient of SHOWKAKAN KYOUSAKU or breading 3. SHINKOUSEI infectious patient 4. Urgent operation patient 5. ZOUKIFUZEN patient 6. Uncontrollable patients together with diabetes mellitus and treated with insulin 7. Suspected cases allergic to yeasts 8. Patient who has been treated with chemotherapy 9. Other patients who are considered to be ruled out by the doctor concerned |
Related Information
| Primary Sponsor | Research institute of cancer chemotherapy |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Nippon Biothera Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tsunesuke Kajimoto, Ph.D. |
| Address | 2-3-26 Kudanminami,Chiyoda-ku,Tokyo 102-00074,Japan Japan |
| Telephone | 03-5276-0212 |
| t.kajimoto@nipponbiothera.co.jp | |
| Affiliation | Nippon Biothera Co., Ltd. Healthcare Division |
| scientific contact | |
| Name | Professor Kenji Ogawa |
| Address | 2-1-10 Nishioku,akawa-ku,Tokyo 1160-8567,Japan Japan |
| Telephone | 03-3810-1111 |
| Affiliation | Tokyo wemen college of medicine, East clinical center Surgicaldepartment |