Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication

Helicobacter Pylori Infection Clinical Trial

— LactoBismu  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03925818
• Other study ID #: 2358/CE
• Status: Terminated
• Phase: N/A
• Start date: August 29, 2017
• Est. completion date: December 23, 2018

Study information

• Verified date: April 2019
• Source: Università degli Studi di Sassari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates the efficacy of a b.i.d. quadruple therapy containing Pylera® or L. reuteri for H. pylori infection.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 99
• Est. completion date: December 23, 2018
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Positive for H. pylori infection

Exclusion Criteria:

• Presence of malignancy

• Pregnancy or lactation

• Clinically significant diseases

• History of drug or alcohol abuse

• Allergy to pantoprazole or to any component of regimens used in the study

• Use of anti-secretory drugs, antibiotics or probiotics 4 weeks preceding the enrollment.

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• Bismuth Subcitrate Potassium
Pylera capsules

Dietary Supplement:
• Gastrus
Gastrus 1 tablet

Locations

Country	Name	City	State
Italy	Clinica Medica, Dipartimento di Medicina Clinica e Sperimentale	Sassari	SS

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Sassari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori eradication rate	a negative 13C-urea breath test and/or a negative stool antigen test	30-40 days after the end of treatment
Secondary	Compliance and side effects evaluation	Patient interview at the end of treatment	30-40 days