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

Università degli Studi di Sassari

Status: Terminated

Conditions: Helicobacter Pylori Infection

Treatments: Dietary Supplement: Gastrus; Drug: Bismuth Subcitrate Potassium

Study type: Interventional

Funder types: Other

Identifiers

NCT03925818

2358/CE

Details and patient eligibility

About

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

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

B.I.D. TMPPI + Lactobacillus-10

Experimental group

Description:

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

Treatment:

Drug: Bismuth Subcitrate Potassium

B.I.D. Bismuth

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Gastrus