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Trial record 32 of 215 for:    TETRACYCLINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03925818
Recruitment Status : Terminated (Lactobacillus reuteri (Gastrus®) was not anymore available in the region)
First Posted : April 24, 2019
Last Update Posted : April 26, 2019
Information provided by (Responsible Party):
Maria Pina Dore, 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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Bismuth Subcitrate Potassium Dietary Supplement: Gastrus Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 29, 2017
Actual Primary Completion Date : November 29, 2018
Actual Study Completion Date : December 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

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 Name: L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475

Primary Outcome Measures :
  1. Helicobacter pylori eradication rate [ Time Frame: 30-40 days after the end of treatment ]
    a negative 13C-urea breath test and/or a negative stool antigen test

Secondary Outcome Measures :
  1. Compliance and side effects evaluation [ Time Frame: 30-40 days ]
    Patient interview at the end of treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03925818

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Clinica Medica, Dipartimento di Medicina Clinica e Sperimentale
Sassari, SS, Italy, 07100
Sponsors and Collaborators
Università degli Studi di Sassari
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Principal Investigator: MARIA P Dore, MD, PhD Università degli Studi di Sassari

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Responsible Party: Maria Pina Dore, Professor, Università degli Studi di Sassari Identifier: NCT03925818     History of Changes
Other Study ID Numbers: 2358/CE
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Pina Dore, Università degli Studi di Sassari:
Lactobacillus reuteri; Bismuth; Helicobacter pylori;
Additional relevant MeSH terms:
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Bismuth tripotassium dicitrate
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors