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 |
| Protocol serial number | N/A |
| Sponsor | Hospital Clinic of the School of Medicine of the University of São Paulo (Brazil) |
| Funder | Hospital Clinic of the School of Medicine of the University of São Paulo (Brazil) |
- 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
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 |
|---|---|
| tomasnavarro@uol.com.br |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised double-blind placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
1. Adverse effects |
| Completion date | 25/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 77 |
| 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
05403-000
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
