Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication

Not Applicable

Terminated

• Conditions: Helicobacter Pylori Infection
• Interventions: Dietary Supplement: Gastrus; Drug: Bismuth Subcitrate Potassium

• Registration Number: NCT03925818
• Lead Sponsor: Università degli Studi di Sassari

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 Timeline

• Study Start: 2017-08-29
• Primary Completion: 2018-11-29
• Study Completion: 2018-12-23
• Status Verified: 2019-04
• Study First Submitted: 2019-04-19
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-24
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B.I.D. Bismuth	Gastrus	pantoprazole 20 mg and the same doses of antibiotics administered as tetracycline 250 mg, and metronidazole 250 mg plus 1 cp (140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride administered) x 2 all drugs twice-a-day given with the midday and evening meals for 10 days
B.I.D. TMPPI + Lactobacillus-10	Bismuth Subcitrate Potassium	pantoprazole 20 mg, tetracycline 500 mg, and metronidazole 500 mg twice a day supplemented with 1 capsule (2 x 108 CFU of L. reuteri DSM 17938 plus 2 x 108 CFU of L. reuteri ATCC PTA 6475) a day in the afternoon, given with the midday and evening meals for 10 days

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication rate	30-40 days after the end of treatment	a negative 13C-urea breath test and/or a negative stool antigen test

Secondary Outcome Measures

Name	Time	Method
Compliance and side effects evaluation	30-40 days	Patient interview at the end of treatment

Trial Locations

Locations (1)

Clinica Medica, Dipartimento di Medicina Clinica e Sperimentale; 🇮🇹 Sassari, SS, Italy