Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT01706393
Status:
UNKNOWN
Last Update Posted:
2013-04-19
First Post:
2012-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Pts(Get Pelvic/Abdominal Rtx)
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Double Blind Placebo Controled Randomized Trial, Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Patients Who Get Pelvic/Abdominal Radiotherapy
Status:
UNKNOWN
Status Verified Date:
2013-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RTxIMprobio
Brief Summary:
The purpose of this study is to evaluate the effect of probiotics to improve the intestinal microbiome in malignancy patients who get pelvic/abdominal radiotherapy.
Detailed Description:
Pelvic/abdominal radiotherapy carries a risk of complications. Acute complications include diarrhea, abdominal pain, inflammatory change in the small intestine. Radiation creates changes in bacterial microbiome, the vascular permeability of the mucosal cells and in intestinal motility. Probiotics were known to improve gastrointestinal function. This is a randomized, double-blind, placebo-controlled study involving 26 patients designed to evaluate the effect of probiotics to change the intestinal microbiome in in patients undergoing concurrent pelvic/abdominal RT.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: