Helicobacter Pylori Infection
Conditions
Keywords
Lactobacillus reuteri; Bismuth; Helicobacter pylori;
Brief summary
This study investigates the efficacy of a b.i.d. quadruple therapy containing Pylera® or L. reuteri for H. pylori infection.
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.
Interventions
DRUGBismuth Subcitrate Potassium
Pylera capsules
DIETARY_SUPPLEMENTGastrus
Gastrus 1 tablet
Sponsors
Università degli Studi di Sassari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori eradication rate | 30-40 days after the end of treatment | a negative 13C-urea breath test and/or a negative stool antigen test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance and side effects evaluation | 30-40 days | Patient interview at the end of treatment |
Countries
Italy
Outcome results
None listed