Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-02-24 @ 8:49 AM
Study NCT ID:
NCT03925818
Status:
TERMINATED
Last Update Posted:
2019-04-26
First Post:
2019-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication
Sponsor:
Università degli Studi di Sassari
Organization:
Study Overview
Official Title:
Twice-a-day PPI, Tetracycline, Metronidazolequadruple Therapy With Pylera® or Lactobacillus Reuteri for Treatment naïve or for Retreatment of H. Pylori: Two Randomized Pilot Studies
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lactobacillus reuteri (Gastrus®) was not anymore available in the region
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LactoBismu
Brief Summary:
This study investigates the efficacy of a b.i.d. quadruple therapy containing Pylera® or L. reuteri for H. pylori infection.
Detailed Description:
Bismuth, metronidazole and tetracycline yielded high cure rates for H. pylori infection. Earlier studies suggested that the bismuth quadruple therapy may be effective when given twice-a-day rather than q.i.d. and that b.i.d. therapy was associated with fewer side effects. The addition of the probiotic Lactobacillus reuteri (Gastrus®) to Lactobacillus reuteri (Gastrus®) that has been shown to increase the cure rates by 10-14%. In another study bismuth supplementation with L. reuteri DSM 17938, in a modified low dose quadruple therapy provided good eradication rates (93.3%; 95% CI : 85-99%) in clinical practice.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: