Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-26 @ 11:16 AM
Study NCT ID:
NCT01790035
Status:
TERMINATED
Last Update Posted:
2022-03-16
First Post:
2013-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
A Phase I and Randomized Controlled Phase II Trial of the Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LGG
Brief Summary:
Phase 3 placebo-controlled trial to determine efficacy of the probiotic LGG for reducing acute treatment related GI toxicity in patients with GI malignancy with phase 1 safety lead-in.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: