Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication

NCT03925818 | Terminated

• 1 other identifier: 2358/CE
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Helicobacter Pylori Infection

Keywords

Lactobacillus reuteri; Bismuth; Helicobacter pylori;

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compliance and side effects evaluation

  30-40 days

Study Arms (2)

B.I.D. TMPPI + Lactobacillus-10

EXPERIMENTAL

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

B.I.D. Bismuth

ACTIVE COMPARATOR

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

Interventions

Bismuth Subcitrate Potassium DRUG

Pylera capsules

Also known as: Pylera, Metronidazole, Tetracycline, pantoprazole, Bismuth

B.I.D. TMPPI + Lactobacillus-10

Gastrus DIETARY_SUPPLEMENT

Gastrus 1 tablet

Also known as: L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475

B.I.D. Bismuth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Positive for H. pylori infection

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Sassari: lead

Study Sites (1)

Clinica Medica, Dipartimento di Medicina Clinica e Sperimentale

Sassari, SS, 07100, Italy

Location

MeSH Terms

Interventions

Metronidazole; Tetracycline; Pantoprazole; Bismuth

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals

Study Officials

• MARIA P Dore, MD, PhD

  Università degli Studi di Sassari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 24, 2019
• Study Start: August 29, 2017
• Primary Completion: November 29, 2018
• Study Completion: December 23, 2018
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

IT (1)