Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-29

Study Completion Date

2018-12-23

Brief Summary

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

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Detailed Description

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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.

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Bismuth Subcitrate Potassium

Intervention Type DRUG

Pylera capsules

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

Group Type ACTIVE_COMPARATOR

Gastrus

Intervention Type DIETARY_SUPPLEMENT

Gastrus 1 tablet

Interventions

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Bismuth Subcitrate Potassium

Pylera capsules

Intervention Type DRUG

Gastrus

Gastrus 1 tablet

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Pylera Metronidazole, Tetracycline, pantoprazole, Bismuth L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No