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

ISRCTN	ISRCTN04714018
DOI	https://doi.org/10.1186/ISRCTN04714018
Secondary identifying numbers	N/A

Submission date: 11/01/2011
Registration date: 31/01/2011
Last edited: 12/09/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Tomas Navarro-Rodriguez
Scientific

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

Phone	+55 11 3069 7830
Email	tomasnavarro@uol.com.br

Study information

Study design	Prospective randomised double-blind placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Ethics Committee of the Clinic of Hospital of the School of Medicine of the University of Sao Paulo approved on the 18/04/2007
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Lansoprazole, furazolidone, tetracycline, probiotic (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum and Streptococcus Faecium)
Primary outcome measure	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 study start date	20/04/2007
Completion date	25/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	51 with peptic ulcer and 26 with functional dyspepsia
Key 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
Key exclusion criteria	Previously treated Helicobacter pylori infection
Date of first enrolment	20/04/2007
Date of final enrolment	25/09/2010

Locations

Countries of recruitment

Brazil

Study participating centre

Hospital Clinic of the School of Medicine of the University of São Paulo

São Paulo
05403-000
Brazil

Sponsor information

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

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

Phone	+55 11 3069 7830
Email	tomasnavarro@uol.com.br
"ROR"	https://ror.org/036rp1748

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/03/2013		Yes	No