Gastrointestinal DiseasesPhase 4NCT00424905
DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect
A Phase 4 study testing Bacillus clausii in people with Gastrointestinal Diseases, run by Sanofi at 1 site in Italy.
Trial summary
To assess the effects of Bacillus clausii (Enterogermina®) on fecal microbial flora (using Polymerase Chain Reaction - Denaturing Gradient Gel Electrophoresis - PCR-DGGE - Method) in antibiotic-treated children with complicated acute otitis media or beta-hemolytic streptococcal pharyngo-tonsillitis. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- Bacillus clausii
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2006to Dec 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects with persistency of symptoms and requiring antibiotics for bacterial upper respiratory tract infections, i.e. complicated acute otitis media (diagnosed by otoscopic examination) or beta-haemolytic streptococcal pharyngo-tonsillitis (diagnosed by pharyngeal swab and rapid antigen detection test or positive culture);
- Outpatients or patients attending an emergency room for both diagnoses, and inpatients in case of complicated acute otitis media;
- Written informed consent from both parents.
Who cannot join
- History of clinically significant chronic diseases, or chronic diseases necessitating the use of continuous drug therapies, or of any disease that may interfere with the successful completion or the objectives of the trial;
- Clinical evidence of relevant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological or of any disease that may interfere with the successful completion or the objectives of the trial;
- Use of antibiotics, prebiotics or probiotics (medications or dietetic supplements) in the last 2 weeks prior to study entry;
- Hypersensitivity to the investigational product;
- Subjects enrolled in another trial in the previous three months.
- 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: Evaluation of the Effects of Enterogermina, 2 Billion Bacillus Clausii Spores, on the Intestinal Flora of Children Antibiotic Treated for Bacterial Upper Respiratory Tract Infections: Open, Pilot Study.
To assess the effects of Bacillus clausii (Enterogermina®) on fecal microbial flora (using Polymerase Chain Reaction - Denaturing Gradient Gel Electrophoresis - PCR-DGGE - Method) in antibiotic-treated children with complicated acute otitis media or beta-hemolytic streptococcal pharyngo-tonsillitis.
- Conditions
- Gastrointestinal Diseases
- Being tested
- Bacillus clausii
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus clausiiDrug
2 Enterogermina vials/day for 12 to 17 days (i.e. during the 5 to 10-days antibiotic treatment and for 7 days thereafter.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Enterogermina® vials containing 2×109 spores of polyantibiotic resistant Bacillus clausii (test drug) Receives: Drug: Bacillus clausii |
| 2 | No intervention | No treatment (reference group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis.
Measured: between samples obtained at baseline and follow-up
Secondary outcomes (4)
Changes from baseline of body weight
Measured: During the total study period
Assessment of abdominal symptoms
Measured: Daily
Presence of Bacillus clausii spores in feces
Measured: after heat shock treatment on selective medium.
Number and rate of patients with GI symptoms and time to first development of symptoms.
Measured: recorded in a daily diary card for the total study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Georges Paizis, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424905
- Sponsor's protocol ID
- PM_L_0199
- Other IDs
- EudraCT # : 2006-002482-39
- Status last verified
- Nov 2008
- First submitted
- 19 Jan 2007
- Last updated
- 1 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Enterogermina, 2 Billion Bacillus Clausii Spores, on the Intestinal Flora of Children Antibiotic Treated for Bacterial Upper Respiratory Tract Infections: Open, Pilot Study.
- ClinicalTrials.gov ID
- NCT00424905
- Acronym / sponsor ID
- PM_L_0199
- Conditions
- Gastrointestinal Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2007 (actual)
- First posted
- 22 Jan 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 assess the effects of Bacillus clausii (Enterogermina®) on fecal microbial flora (using Polymerase Chain Reaction - Denaturing Gradient Gel Electrophoresis - PCR-DGGE - Method) in antibiotic-treated children with complicated acute otitis media or beta-hemolytic streptococcal pharyngo-tonsillitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bacillus clausiiEnterogermina® vials containing 2×109 spores of polyantibiotic resistant Bacillus clausii (test drug) |
| 2 | No intervention | –No treatment (reference group) |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects with persistency of symptoms and requiring antibiotics for bacterial upper respiratory tract infections, i.e. complicated acute otitis media (diagnosed by otoscopic examination) or beta-haemolytic streptococcal pharyngo-tonsillitis (diagnosed by pharyngeal swab and rapid antigen detection test or positive culture);
- Outpatients or patients attending an emergency room for both diagnoses, and inpatients in case of complicated acute otitis media;
- Written informed consent from both parents.
Key exclusion criteria (6 listed)
- History of clinically significant chronic diseases, or chronic diseases necessitating the use of continuous drug therapies, or of any disease that may interfere with the successful completion or the objectives of the trial;
- Clinical evidence of relevant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological or of any disease that may interfere with the successful completion or the objectives of the trial;
- Use of antibiotics, prebiotics or probiotics (medications or dietetic supplements) in the last 2 weeks prior to study entry;
- Hypersensitivity to the investigational product;
- Subjects enrolled in another trial in the previous three months.
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 clausii2 Enterogermina vials/day for 12 to 17 days (i.e. during the 5 to 10-days antibiotic treatment and for 7 days thereafter. | Drug | 1 |
Primary outcome
Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis.
Time frame: between samples obtained at baseline and follow-up
4 secondary outcomes
Changes from baseline of body weight
Time frame: During the total study period
Assessment of abdominal symptoms
Time frame: Daily
Presence of Bacillus clausii spores in feces
Time frame: after heat shock treatment on selective medium.
Number and rate of patients with GI symptoms and time to first development of symptoms.
Time frame: recorded in a daily diary card for the total study period
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 1 Dec 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.
Georges Paizis, MD 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 in people with Gastrointestinal Diseases, run by Sanofi at 1 site in Italy.
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 3 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: finished, as of the sponsor's last update on 1 Dec 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 Italy. 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 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?
Changes of microbial composition of fecal bacterial flora by PCR-DGGE analysis. (time frame: between samples obtained at baseline and follow-up). 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 1 Dec 2008.