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In recent studies, a radiation-induced enteropathy is being reported over 50%. In clinics, probiotics are actively prescribed as a treatment for radiation-induced enteropathy. If probiotics can be used during radiation therapy to prevent or reduce radiation-induced enteropathy, the investigators can 1) reduce the inconvenience which is caused from intestinal toxicity, 2) reduce the unnecessary interruption of radiation therapy, and 3) expect to improve the quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy. |
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| Placebo | Placebo Comparator | Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacillus Licheniformis | Drug | Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with grade 2 or more acute intestinal toxicities | Evaluation using CTCAE version 4.0 | Adverse effect evaluated at 3 months after radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with grade 2 or more chronic intestinal toxicities | Evaluation using CTCAE version 4.0 | Adverse effect occured after 3 months since end of radiation therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Seok Kim, M.D., PhD. | Contact | 82 2 3010 5614 | 5614 | ysk@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Young Seok Kim, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39451742 | Derived | Jo YY, Kim YJ, Lee SH, Kim YS. Prevention of Radiotherapy-Induced Enteropathy by Probiotics (PREP): Double-Blind Randomized Placebo-Controlled Trial. Curr Oncol. 2024 Oct 1;31(10):5889-5895. doi: 10.3390/curroncol31100438. | |
| 34530750 | Derived | Kim YJ, Yu J, Park SP, Lee SH, Kim YS. Prevention of radiotherapy induced enteropathy by probiotics (PREP): protocol for a double-blind randomized placebo-controlled trial. BMC Cancer. 2021 Sep 16;21(1):1032. doi: 10.1186/s12885-021-08757-w. |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Drug | Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy. |
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