DiarrheaPhase 3NCT00265369
TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children
A Phase 3 study testing Spores of Bacillus Clausii Probiotic Strain in people with Diarrhea, run by Sanofi at 2 sites in 2 countries.
Trial summary
Primary objective: To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days. Secondary objective: To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo. Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Diarrhea
- What is being tested?
- Spores of Bacillus Clausii Probiotic Strain
- How many people
- 420 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2004to not given
- 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 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants or Children
- Non hospitalized infants or children
- With acute diarrhea evident for less than 48 hours
- Having had three or more watery stools during the preceding 24 hours
Who cannot join
- Infants or Children
- With blood stools
- Having been treated with antibiotics or probiotics within the two weeks before the enrollment
- Suffering from dehydration defined by a weight loss of at least 5% or by the presence of a skin fold
- With an history of seizures
- With immunosuppressive conditions
Show all 15Show fewer
- With a current status requiring an antibiotic treatment
- Suffering from a chronic disease including chronic diarrhea whatever the origin
- Having received before inclusion one of the following treatments:
- Probiotics
- Prebiotics
- Drugs with adsorbing properties
- Drugs that modify intestinal secretion like bismuth subsalicylate, acetorphan
- Drugs that modify intestinal motility (opiates such as loperamide, atropine and other cholinergic agents).
- Having participated in another clinical trial in the last 3 months prior to the start of the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Comparative Efficacy and Safety of a Bacillus Clausii Probiotic Strain Versus Placebo in the Treatment of Acute Diarrhoea in Children
Primary objective:
- To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days.
Secondary objective:
- To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.
- Conditions
- Diarrhea
- Being tested
- Spores of Bacillus Clausii Probiotic Strain
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spores of Bacillus Clausii Probiotic StrainDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrhoea as counted from the first intake of the investigational product up to the first appearance of a loose stool followed by two-consecutive normal stools
Secondary outcomes (1)
Number of infants/children with normal stools at D3, D4, D5, D6 and D7;Mean number of stools per day;Occurrence of vomiting episodes per day after enrolment;Parents'overall global assessment of efficacy at the end of the treatment;other safety criteria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 420 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gilles Perdriset, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265369
- Sponsor's protocol ID
- C_9240
- Status last verified
- Jan 2011
- First submitted
- 4 Nov 2005
- Last updated
- 11 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Safety of a Bacillus Clausii Probiotic Strain Versus Placebo in the Treatment of Acute Diarrhoea in Children
- ClinicalTrials.gov ID
- NCT00265369
- Acronym / sponsor ID
- C_9240
- Conditions
- Diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2004
- First posted
- 14 Dec 2005 (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.
Primary objective:
- To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days.
Secondary objective:
- To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants or Children
- Non hospitalized infants or children
- With acute diarrhea evident for less than 48 hours
- Having had three or more watery stools during the preceding 24 hours
Key exclusion criteria (15 listed)
- Infants or Children
- With blood stools
- Having been treated with antibiotics or probiotics within the two weeks before the enrollment
- Suffering from dehydration defined by a weight loss of at least 5% or by the presence of a skin fold
- With an history of seizures
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 |
|---|---|---|
| Spores of Bacillus Clausii Probiotic Strain | Drug | – |
Primary outcome
Duration of diarrhoea as counted from the first intake of the investigational product up to the first appearance of a loose stool followed by two-consecutive normal stools
1 secondary outcome
Number of infants/children with normal stools at D3, D4, D5, D6 and D7;Mean number of stools per day;Occurrence of vomiting episodes per day after enrolment;Parents'overall global assessment of efficacy at the end of the treatment;other safety criteria
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 11 Jan 2011.
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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.
Gilles Perdriset, MD study director
Sanofi
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Spores of Bacillus Clausii Probiotic Strain in people with Diarrhea, run by Sanofi at 2 sites in 2 countries.
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 15 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 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. 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 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?
Duration of diarrhoea as counted from the first intake of the investigational product up to the first appearance of a loose stool followed by two-consecutive normal stools. 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 11 Jan 2011.