Diarrhea, InfantilePhase 4PADRENCT00447161
Preventing Antibiotic-Associated DiarRhea Using Erceflora
A Phase 4 study testing Bacillus Clausii Multi ATB Resist in people with Diarrhea, Infantile, run by Sanofi at 1 site in Philippines.
Trial summary
To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Diarrhea, Infantile
- What is being tested?
- Bacillus Clausii Multi ATB Resist
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 323 participants
- Where
- 1 sitePhilippines
- Study dates
- Jul 2006to Oct 2007
- Phase
- Phase 4
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinically stable children with mild to moderate illness admitted for treatment of bacterial infection.
Who cannot join
- Children with unstable medical condition
- In any form of immunocompromized state
- With contraindication to take medication
- Has taken antibiotics for 3 weeks before start of trial.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bacillus Clausii in Preventing Antibiotic-Associated Diarrhea Among Filipino Infant and Children: A Multi-Center, Randomized, Open-Label Controlled (Treatment vs No Treatment) Clinical Trial of Efficacy and Safety
To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.
- Conditions
- Diarrhea, Infantile
- Being tested
- Bacillus Clausii Multi ATB Resist, Placebo
- Medical subject headings
- Diarrhea, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus Clausii Multi ATB ResistDrug
Twice daily dose of 1 vial of 1x10^9 of Bacillus clausii spores, orally suspension in water
PlaceboDrug
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bacillus Clausii Multi ATB Resist Receives: Drug: Bacillus Clausii Multi ATB Resist |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the incidence of antibiotic-associated diarrhea (relative risk)
Measured: From baseline to end of treatment
All adverse event regardless of seriousness or relationship to the study drug
Measured: From baseline to end of treatment
Secondary outcomes (4)
Reduction in the number of antibiotic-associated diarrhea events per day
Measured: From baseline to end of treatment
Reduction in the severity of diarrhea events
Measured: From baseline to end of treatment
Reduction in Gastrointestinal-related symptoms (nausea, vomiting, abdominal pain)over-all reduction in the number of hospitalization days beween control and treatment groups.
Measured: From baseline to end of treatment
Reduction in C. dificille -associated diarrhea.
Measured: From baseline to end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startJul 2006
- Primary completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea, InfantileStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paz Figueroa, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447161
- Sponsor's protocol ID
- ENTER_L_01125
- Acronym
- PADRE
- Status last verified
- Sep 2008
- First submitted
- 13 Mar 2007
- Last updated
- 5 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacillus Clausii in Preventing Antibiotic-Associated Diarrhea Among Filipino Infant and Children: A Multi-Center, Randomized, Open-Label Controlled (Treatment vs No Treatment) Clinical Trial of Efficacy and Safety
- ClinicalTrials.gov ID
- NCT00447161
- Acronym / sponsor ID
- PADRE / ENTER_L_01125
- Conditions
- Diarrhea, Infantile
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Oct 2007 (actual)
- First posted
- 14 Mar 2007 (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.
To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bacillus Clausii Multi ATB ResistBacillus Clausii Multi ATB Resist |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Clinically stable children with mild to moderate illness admitted for treatment of bacterial infection.
Key exclusion criteria (5 listed)
- Children with unstable medical condition
- In any form of immunocompromized state
- With contraindication to take medication
- Has taken antibiotics for 3 weeks before start of trial.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| Bacillus Clausii Multi ATB ResistTwice daily dose of 1 vial of 1x10^9 of Bacillus clausii spores, orally suspension in water | Drug | 1 |
| PlaceboMatched placebo | Drug | 2 |
Primary outcome
Reduction in the incidence of antibiotic-associated diarrhea (relative risk)
Time frame: From baseline to end of treatment
All adverse event regardless of seriousness or relationship to the study drug
Time frame: From baseline to end of treatment
4 secondary outcomes
Reduction in the number of antibiotic-associated diarrhea events per day
Time frame: From baseline to end of treatment
Reduction in the severity of diarrhea events
Time frame: From baseline to end of treatment
Reduction in Gastrointestinal-related symptoms (nausea, vomiting, abdominal pain)over-all reduction in the number of hospitalization days beween control and treatment groups.
Time frame: From baseline to end of treatment
Reduction in C. dificille -associated diarrhea.
Time frame: From baseline to end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2008.
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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.
Paz Figueroa study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bacillus Clausii Multi ATB Resist in people with Diarrhea, Infantile, run by Sanofi at 1 site in Philippines.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 5 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in the incidence of antibiotic-associated diarrhea (relative risk) (time frame: From baseline to end of treatment). The study lists 2 primary outcomes in all. 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 5 Sep 2008; AzTrials last refreshed its copy on 26 Oct 2026.