Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication (LactoBismu)

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

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

Study Overview

• Status: Terminated
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Bismuth Subcitrate Potassium; Dietary supplement: Gastrus

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • SS
    • Sassari, SS, Italy, 07100
      • Clinica Medica, Dipartimento di Medicina Clinica e Sperimentale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B.I.D. TMPPI + Lactobacillus-10; 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	Drug: Bismuth Subcitrate Potassium; Pylera capsules; Other Names: Pylera; Metronidazole, Tetracycline, pantoprazole, Bismuth
Active Comparator: B.I.D. Bismuth; 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	Dietary supplement: Gastrus; Gastrus 1 tablet; Other Names: L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance and side effects evaluation	Patient interview at the end of treatment	30-40 days

Collaborators and Investigators

• Sponsor: Università degli Studi di Sassari
• Investigators: Principal Investigator: MARIA P Dore, MD, PhD, Università degli Studi di Sassari

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2017
• Primary Completion (Actual): November 29, 2018
• Study Completion (Actual): December 23, 2018

Study Registration Dates

• First Submitted: April 19, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Lactobacillus reuteri; Bismuth; Helicobacter pylori
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Antacids; Metronidazole; Bismuth; Pantoprazole; Tetracycline; Bismuth tripotassium dicitrate
• Other Study ID Numbers: 2358/CE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No