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Association of a probiotic to a Helicobacter pylori eradication scheme does not increase eradication rate neither decrease the adverse events

Association of a probiotic to a Helicobacter pylori eradication scheme does not increase eradication rate neither decrease the adverse events: a prospective, randomised double-blind placebo controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN04714018
Enrollment
77
Registered
2011-01-31
Start date
2007-04-20
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic ulcer, functional dyspepsia Digestive System Peptic ulcer

Interventions

77 Hp positive patients without previous treatments to Hp were enrolled. Hp status was confirmed with at least two positive tests (urease, histologic or breath test with 14 carbon). Patients were divi

Sponsors

Hospital Clinic of the School of Medicine of the University of São Paulo (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Peptic ulcer disease or functional dyspepsia 2. H. pylori infected status was determined by concordance of the at least two biopsy-based diagnostic tests (rapid urease test, histology or 14C labeled urea breath test) 3. Aged 18 to 70 years, either sex

Exclusion criteria

Exclusion criteria: Previously treated Helicobacter pylori infection

Design outcomes

Primary

MeasureTime frame
Treatment efficacy was determined by bacterial negativity in at least two diagnostic methods: rapid urease test, histological examination of gastric antrum and corpus mucosa samples or 14C urea breath test, performed 60 days after completion of the eradication treatment.

Secondary

MeasureTime frame
1. Adverse effects 2. Compliance to treatment

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026