Condition category
Digestive System
Date applied
11/01/2011
Date assigned
31/01/2011
Last edited
12/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tomas Navarro-Rodriguez

ORCID ID

Contact details

Hospital Clinic of the School of Medicine of the University of São Paulo
Department of Gastroenterology - Clinical Gastroenterology
Av. Dr. Eneas Carvalho de Aguiar
255
ICHC
9th floor
Office 9159
São Paulo
05403-000
Brazil
+55 11 3069 7830
tomasnavarro@uol.com.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

The Helicobacter pylori (Hp) eradication schemes have frequent adverse events, leading patients to interrupt the treatment. Consequently, therapeutic failure and bacteria resistance can develop. Proton pump inhibitor (PPI), furazolidone and tetracycline (PPI/F/T) is cheap, presents low bacteria resistance, has high eradication rates, but with many adverse events. Among these events, alterations in gut habits are the most important and secondary to changes in intestinal microflora due to antibiotic treatment. Probiotics are an excellent tool to control the bacteria overgrowing, helping prevent or decrease the adverse events consequent to antibiotics use.

Ethics approval

Ethics Committee of the Clinic of Hospital of the School of Medicine of the University of Sao Paulo approved on the 18/04/2007

Study design

Prospective randomised double-blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Peptic ulcer, functional dyspepsia

Intervention

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 divided in two groups:
1. Lansoprazole 30 mg, furazolidone 200 mg, tetracycline 500 mg twice daily (bid) and probiotic (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum and Streptococcus Faecium) (n = 40) for 7 days
2. Lansoprazole 30 mg, furazolidone 200 mg, tetracycline 500 mg bid and probiotic placebo (n = 37) for 7 days

The probiotic or probiotic placebo was maintained for 23 more days. All patients were clinically evaluated at initial visit, 7, 30 and 60 days. In the final visit the patients had the Hp eradication confirmed using at least two tests that had to be negative (urease, histologic or C14UBT). The following symptoms were investigated: epigastric pain, heartburn, nausea, vomiting, diarrhoea, bloating and abdominal pain. Each symptom was quantified using the following score: zero (without symptom), one (mild intensity), two (moderate intensity) and three (severe intensity).

Intervention type

Drug

Phase

Not Applicable

Drug names

Lansoprazole, furazolidone, tetracycline, probiotic (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum and Streptococcus Faecium)

Primary outcome measures

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 outcome measures

1. Adverse effects
2. Compliance to treatment

Overall trial start date

20/04/2007

Overall trial end date

25/09/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

51 with peptic ulcer and 26 with functional dyspepsia

Participant exclusion criteria

Previously treated Helicobacter pylori infection

Recruitment start date

20/04/2007

Recruitment end date

25/09/2010

Locations

Countries of recruitment

Brazil

Trial participating centre

Hospital Clinic of the School of Medicine of the University of São Paulo
São Paulo
05403-000
Brazil

Sponsor information

Organisation

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

Sponsor details

c/o Tomas Navarro-Rodriguez
Department of Gastroenterology - Clinical Gastroenterology
Av. Dr. Eneas Carvalho de Aguiar
255
ICHC
9th floor
Office 9159
São Paulo
05403-000
Brazil
+55 11 3069 7830
tomasnavarro@uol.com.br

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23530767

Publication citations

  1. Results

    Navarro-Rodriguez T, Silva FM, Barbuti RC, Mattar R, Moraes-Filho JP, de Oliveira MN, Bogsan CS, Chinzon D, Eisig JN, Association of a probiotic to a Helicobacter pylori eradication regimen does not increase efficacy or decreases the adverse effects of the treatment: a prospective, randomized, double-blind, placebo-controlled study., BMC Gastroenterol, 2013, 13, 56, doi: 10.1186/1471-230X-13-56.

Additional files

Editorial Notes