GastroenteritisPhase 3ENIGMANCT00457353
ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children
A Phase 3 study testing Bacillus Clausii and Oral rehydration therapy in people with Gastroenteritis, run by Sanofi at 1 site in India.
Trial summary
Primary: To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea in children Secondary: To evaluate the safety of Enterogermina® in acute diarrhea in Indian children Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Gastroenteritis
- What is being tested?
- Bacillus Clausii and Oral rehydration therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2007to Dec 2007
- 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 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Non hospitalised infants and children attending clinic/outpatients with acute diarrhea (>3 liquid or watery stools occurring in a 24-hour period) of less than 48 hours duration
Who cannot join
- History of presence of blood, pus, or mucus in stools
- Severe dehydration (World Health Organization criteria)
- Severely malnourished patients
- Treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment
- History of conditions known to producing immunodeficiency (Acquired Immune Deficiency Syndrome, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc)
- Known hypersensitivity to Bacillus clausii or other probiotics.
- 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: Phase III Comparative Study to Assess the Efficacy and Safety of Oral Rehydration Therapy (ORT) in Combination With Spores of Bacillus Clausii (Enterogermina)Versus ORT Alone, Administered for 5 Days With the Treatment of Acute Diarrhea in Children.
Primary:
- To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea in children
Secondary:
- To evaluate the safety of Enterogermina® in acute diarrhea in Indian children
- Conditions
- Gastroenteritis
- Being tested
- Bacillus Clausii, Oral rehydration therapy
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus ClausiiDrug
For 5 days
Oral rehydration therapyOther
For 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Administration of oral rehydration therapy with Bacillus clausii probiotic strain (1 vial twice daily, each vial containing 2 billion spores of Bacillus clausii) Receives: Drug: Bacillus Clausii |
| 2 | Placebo comparator | Administration of Oral rehydration therapy Receives: Other: Oral rehydration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in duration of diarrhea
Measured: Throughout the treatment period
Incidence of adverse events
Measured: Throughout the study period
Secondary outcomes (5)
Mean number of stools per day
Measured: Throughout the treatment period
Effect on consistency of stools
Measured: Throughtout the treatment period
Vomiting episodes per day
Measured: Throughout the treatment period
Requirement of unscheduled intravenous transfusion
Measured: Throughout the study period
Need for hospitalization
Measured: Throughout the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenteritisStudies 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
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shah Pratik, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457353
- Sponsor's protocol ID
- ENTER_L_01486
- Acronym
- ENIGMA
- Status last verified
- Jan 2009
- First submitted
- 5 Apr 2007
- Last updated
- 21 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Comparative Study to Assess the Efficacy and Safety of Oral Rehydration Therapy (ORT) in Combination With Spores of Bacillus Clausii (Enterogermina)Versus ORT Alone, Administered for 5 Days With the Treatment of Acute Diarrhea in Children.
- ClinicalTrials.gov ID
- NCT00457353
- Acronym / sponsor ID
- ENIGMA / ENTER_L_01486
- Conditions
- Gastroenteritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2007 (actual)
- First posted
- 6 Apr 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.
Primary:
- To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea in children
Secondary:
- To evaluate the safety of Enterogermina® in acute diarrhea in Indian children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Bacillus ClausiiAdministration of oral rehydration therapy with Bacillus clausii probiotic strain (1 vial twice daily, each vial containing 2 billion spores of Bacillus clausii) |
| 2 | Placebo comparator | Other: Oral rehydration therapyAdministration of Oral rehydration therapy |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Non hospitalised infants and children attending clinic/outpatients with acute diarrhea (>3 liquid or watery stools occurring in a 24-hour period) of less than 48 hours duration
Key exclusion criteria (7 listed)
- History of presence of blood, pus, or mucus in stools
- Severe dehydration (World Health Organization criteria)
- Severely malnourished patients
- Treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment
- History of conditions known to producing immunodeficiency (Acquired Immune Deficiency Syndrome, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc)
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 ClausiiFor 5 days | Drug | 1 |
| Oral rehydration therapyFor 5 days | Other | 2 |
Primary outcome
Reduction in duration of diarrhea
Time frame: Throughout the treatment period
Incidence of adverse events
Time frame: Throughout the study period
5 secondary outcomes
Mean number of stools per day
Time frame: Throughout the treatment period
Effect on consistency of stools
Time frame: Throughtout the treatment period
Vomiting episodes per day
Time frame: Throughout the treatment period
Requirement of unscheduled intravenous transfusion
Time frame: Throughout the study period
Need for hospitalization
Time frame: Throughout the treatment 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 21 Jan 2009.
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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.
Shah Pratik 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 3 study testing Bacillus Clausii and Oral rehydration therapy in people with Gastroenteritis, run by Sanofi at 1 site in India.
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 7 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 21 Jan 2009. 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 India. 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 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?
Reduction in duration of diarrhea (time frame: Throughout the treatment period). 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 21 Jan 2009.