AntibioticsPhase 3ACROSSNCT01463943
Non-Inferiority Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® in the Prevention of Antibiotic-Associated Diarrhea
A Phase 3 study testing Probiotic in people with Antibiotics, run by Eurofarma Laboratorios S.A. at 17 sites in Brazil.
Trial summary
The study's objective is to evaluate the efficacy and safety of two formulations for the prophylactic treatment of diarrhea in subjects using antibiotics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Antibiotics
- What is being tested?
- Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 17 sitesBrazil
- Study dates
- Feb 2012to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICF signature;
- The subject must agree to follow the instructions and to perform study procedures and visits;
- Male and female subjects between 18 and 65 years old;
- Subjects who have scheduled a treatment or started the use of antibiotics over 24 hours ago:
Who cannot join
- Generalized infection or bacteremia;
- Chronic gastrointestinal diseases (e.g., Crohn's Disease and Irritable Bowel Syndrome);
- Documented chronic diarrhea;
- Acute diarrhea episode within 24 hours prior to the start of antibiotic use. Use of tube feeding (nasogastric and nasoenteral);
- Immunodeficiency (radiotherapy or chemotherapy);
- Use of food with probiotic properties in the last 10 days;
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Brazil17 sites
UNICAMP
Campinas
Unigastro
Campinas
Hospital de Clínicas da Universidade Federal do Paraná
Curitiba
Instituto de Prevenção ao Câncer do Ceará
Fortaleza
Hospital das Clinicas de Porto Alegre
Por to Alegre
Hospital São Lucas da PUC - RS
Porto Alegre
Mãe de Deus Center
Porto Alegre
Universidade Federal de Pernambuco
Recife
Hospital Universitário Clementino Fraga Filho (UFRJ)
Rio de Janeiro
Hospital Universitário Pedro Ernesto
Rio de Janeiro
Pesquisare Saúde S/S Ltda
Santo André
Hospital Albert Einstein
São Paulo
Hospital das Clínicas
São Paulo
Hospital Leforte
São Paulo
Hospital Maternidade Leonor Mendes de Barros
São Paulo
Santa Casa de Misericórdia
São Paulo
Clinica de Alergia Martti Antila
Sorocaba
About this study
Official title: "An Open-Label, Non-Inferiority, Phase III Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® (S. Boulardii - Merck) in the Prevention of Antibiotic-Associated Diarrhea."
The study's objective is to evaluate the efficacy and safety of two formulations for the prophylactic treatment of diarrhea in subjects using antibiotics.
- Conditions
- Antibiotics
- Being tested
- Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Saccharomyces boulardii capsules (200 mg). | Experimental | Not described Receives: Other: Probiotic |
| Floratil® | Active comparator | Not described Receives: Other: Probiotic |
| Saccharomyces boulardii powder (200 mg). | Experimental | Not described Receives: Other: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of diarrhea in subjects using antibiotics
Secondary outcomes (1)
Frequency of diarrhea by severity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startFeb 2012
- Primary completionNov 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: Change company strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntibioticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Fernando Francesconi, MD, Principal investigator, Hospital Mãe de DeusFlavio Quillici, MD, Principal investigator, UnigastroMartti Antila, MD, Principal investigator, Clínica de Alergia Martti AntilaOlavo Mion, MD, Principal investigator, Hospital das Clínicas - SPJosé Angelo Rizzo, MD, Principal investigator, Universidade Federal de PernambucoCarlos Cezar Fritscher, MD, Principal investigator, Hospital São Lucas da PUC - RSRonaldo Damião, MD, Principal investigator, Hospital Universitario Pedro ErnestoFlávio Steinwurtz, MD, Principal investigator, Hospital Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463943
- Sponsor's protocol ID
- EF 121
- Acronym
- ACROSS
- Status last verified
- Oct 2011
- First submitted
- 27 Oct 2011
- Last updated
- 27 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "An Open-Label, Non-Inferiority, Phase III Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® (S. Boulardii - Merck) in the Prevention of Antibiotic-Associated Diarrhea."
- ClinicalTrials.gov ID
- NCT01463943
- Acronym / sponsor ID
- ACROSS / EF 121
- Conditions
- Antibiotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change company strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 2 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study's objective is to evaluate the efficacy and safety of two formulations for the prophylactic treatment of diarrhea in subjects using antibiotics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saccharomyces boulardii capsules (200 mg). | Experimental | Other: Probiotic |
| Floratil® | Active comparator | Other: Probiotic |
| Saccharomyces boulardii powder (200 mg). | Experimental | Other: Probiotic |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ICF signature;
- The subject must agree to follow the instructions and to perform study procedures and visits;
- Male and female subjects between 18 and 65 years old;
- Subjects who have scheduled a treatment or started the use of antibiotics over 24 hours ago:
Key exclusion criteria (6 listed)
- Generalized infection or bacteremia;
- Chronic gastrointestinal diseases (e.g., Crohn's Disease and Irritable Bowel Syndrome);
- Documented chronic diarrhea;
- Acute diarrhea episode within 24 hours prior to the start of antibiotic use. Use of tube feeding (nasogastric and nasoenteral);
- Immunodeficiency (radiotherapy or chemotherapy);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic | Other | Saccharomyces boulardii capsules (200 mg). |
| Probiotic | Other | Saccharomyces boulardii powder (200 mg). |
| Probiotic | Other | Floratil® |
Primary outcome
frequency of diarrhea in subjects using antibiotics
1 secondary outcome
Frequency of diarrhea by severity
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Fernando Francesconi, MD principal investigator
Hospital Mãe de Deus
Flavio Quillici, MD principal investigator
Unigastro
Martti Antila, MD principal investigator
Clínica de Alergia Martti Antila
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic in people with Antibiotics, run by Eurofarma Laboratorios S.A. at 17 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of diarrhea in subjects using antibiotics. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2015.