Acute GastroenteritisPhase 4cadiLAcNCT02169817
Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children
A Phase 4 study testing Bacillus clausii and Oral Rehydration Therapy in people with Acute Gastroenteritis, run by Sanofi at 11 sites in 5 countries.
Trial summary
Primary Objective: To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in the duration of acute community-acquired diarrhea in Latin American children. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Acute Gastroenteritis
- What is being tested?
- Bacillus clausii and Oral Rehydration Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 629 participants
- Where
- 11 sitesin 5 countries
- Study dates
- Jul 2014to Jan 2016
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants or children with acute community-acquired diarrhea (≥3 liquid or watery stools occurring in a 24-hour period):
- with less than 48 hours duration
- aged between 6 months and 5 years of age
- whose parents or legal guardians have given their written informed consent
- with clinical indication for ORT per formula of World Health Organization
Who cannot join
- Infants or children with:
- presence of blood, pus, or mucus in stools
- severe dehydration
- untreatable vomiting
- antibiotics indication for the treatment of this acute diarrhea;
- hospitalization
Show all 17Show fewer
- expected hospitalization for the next hours due to the poor clinical conditions
- treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment (the use of probiotics and prebiotics in dairy food such as yoghurt, cheese, milk prior to the study is permitted)
- previous use (within 48 hours) of kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anticholinergic agents
- indication of any other ORT different from the one prescribed in the study
- chronic diseases including chronic diarrhea
- immunodeficiency (acquired or congenital immunodeficiency)
- other infectious comorbid conditions
- known hypersensitivity to Bacillus clausii (Enterogermina) or other probiotics
- parent/legal guardian who, in the opinion of the Investigator, is unable to complete the patient diary or bring the child for the follow-up visit
- participation in another clinical trial in the last 3 months prior to the start of the study.
- 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
11 sites in 5 countries.
11 sites in 5 countries
Brazil4 sites
076002
Curitiba
076006
Porto Alegre
076003
Salvador
076001
São Paulo
Argentina3 sites
01
Mar del Plata
04
Pilar, Buenos Aires
06
San Miguel de Tucumán
About this study
Official title: Bacillus Clausii in the Treatment of Acute Community-acquired Diarrhea Among Latin American Children (cadiLAc)
Primary Objective:
To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in the duration of acute community-acquired diarrhea in Latin American children.
Secondary Objectives:
To evaluate the clinical safety of Enterogermina in acute diarrhea in children and to demonstrate its effectiveness on stool frequency, stool consistency, and number of vomiting episodes.
To evaluate parent's overall global assessment. To evaluate the safety and effectiveness of Enterogermina in norovirus acute gastroenteritis (AGE).
Read the detailed description
The maximum duration of study participation for each patient can be 10 days.
- Conditions
- Acute Gastroenteritis
- Being tested
- Bacillus clausii, Oral Rehydration Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus clausiiDrug
Also called Enterogermina
Pharmaceutical form:aqueous suspension Route of administration: oral
Oral Rehydration TherapyDrug
Also called Enterolyte
Pharmaceutical form:vials/sachets for solution Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Enterogermina + Enterolyte | Experimental | 2 vials of Enterogermina per day for 5 days and Enterolyte according to investigator´s recommendation Receives: Drug: Bacillus clausii; Drug: Oral Rehydration Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrhea-from the date and time of first intake of investigational product up to date and time of first appearance of a loose stool followed by two consecutive normal stools recorded in the patient diary
Measured: from Day 1 to Day 5
Secondary outcomes (6)
Mean number of stools per day
Measured: Day 1 to Day 5
Effect on consistency of stool
Measured: Day 1 to Day 5
Number of vomiting episodes per day
Measured: Day 1 to Day 5
Parent / Legal guardian's assessment of children's overall acceptance of Enterogermina
Measured: Day 1 to Day 5
Parent / Legal guardian's assessment of children's overall general state
Measured: Day 1 to Day 5
Safety outcome: Adverse events collection reported by the parent / legal guardian in diary and checked by the investigator
Measured: Day 1 to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169817
- Sponsor's protocol ID
- ENTERR06929
- Other IDs
- U1111-1149-1704
- Acronym
- cadiLAc
- Status last verified
- Jan 2016
- First submitted
- 18 Jun 2014
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacillus Clausii in the Treatment of Acute Community-acquired Diarrhea Among Latin American Children (cadiLAc)
- ClinicalTrials.gov ID
- NCT02169817
- Acronym / sponsor ID
- cadiLAc / ENTERR06929
- Conditions
- Acute Gastroenteritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 Jun 2014 (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 effectiveness of treatment with Bacillus clausii probiotic strain (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in the duration of acute community-acquired diarrhea in Latin American children.
Secondary Objectives:
To evaluate the clinical safety of Enterogermina in acute diarrhea in children and to demonstrate its effectiveness on stool frequency, stool consistency, and number of vomiting episodes.
To evaluate parent's overall global assessment. To evaluate the safety and effectiveness of Enterogermina in norovirus acute gastroenteritis (AGE).
Detailed description
The maximum duration of study participation for each patient can be 10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enterogermina + Enterolyte | Experimental | Drug: Bacillus clausii, Drug: Oral Rehydration Therapy2 vials of Enterogermina per day for 5 days and Enterolyte according to investigator´s recommendation |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants or children with acute community-acquired diarrhea (≥3 liquid or watery stools occurring in a 24-hour period):
- with less than 48 hours duration
- aged between 6 months and 5 years of age
- whose parents or legal guardians have given their written informed consent
- with clinical indication for ORT per formula of World Health Organization
Key exclusion criteria (17 listed)
- presence of blood, pus, or mucus in stools
- severe dehydration
- untreatable vomiting
- antibiotics indication for the treatment of this acute diarrhea;
- hospitalization
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 clausiiAlso: EnterogerminaPharmaceutical form:aqueous suspension Route of administration: oral | Drug | Enterogermina + Enterolyte |
| Oral Rehydration TherapyAlso: EnterolytePharmaceutical form:vials/sachets for solution Route of administration: oral | Drug | Enterogermina + Enterolyte |
Primary outcome
Duration of diarrhea-from the date and time of first intake of investigational product up to date and time of first appearance of a loose stool followed by two consecutive normal stools recorded in the patient diary
Time frame: from Day 1 to Day 5
6 secondary outcomes
Mean number of stools per day
Time frame: Day 1 to Day 5
Effect on consistency of stool
Time frame: Day 1 to Day 5
Number of vomiting episodes per day
Time frame: Day 1 to Day 5
Parent / Legal guardian's assessment of children's overall acceptance of Enterogermina
Time frame: Day 1 to Day 5
Parent / Legal guardian's assessment of children's overall general state
Time frame: Day 1 to Day 5
Safety outcome: Adverse events collection reported by the parent / legal guardian in diary and checked by the investigator
Time frame: Day 1 to Day 5
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 2016.
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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.
Clinical Sciences & Operations study director
Sanofi
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bacillus clausii and Oral Rehydration Therapy in people with Acute Gastroenteritis, run by Sanofi at 11 sites in 5 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 5 inclusion and 17 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 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil, Argentina, Peru, Colombia, Mexico. 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?
Duration of diarrhea-from the date and time of first intake of investigational product up to date and time of first appearance of a loose stool followed by two consecutive normal stools recorded in the patient diary (time frame: from Day 1 to Day 5). 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 2016.