Clinical Trial Results:
Bacillus Clausii in the Treatment of Acute Community-acquired Diarrhea Among Latin American Children (cadiLAc)
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Summary
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EudraCT number |
2016-003444-37 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
07 Jan 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Nov 2016
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First version publication date |
19 Nov 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ENTERR06929
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02169817 | ||
WHO universal trial number (UTN) |
U1111-1149-1704 | ||
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Sponsors
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Sponsor organisation name |
Sanofi aventis recherche & développement
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Sponsor organisation address |
1 avenue Pierre Brossolette, Chilly, Mazarin, France, 91380
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Public contact |
Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.com
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Scientific contact |
Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Mar 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Jan 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
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.
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Protection of trial subjects |
The study was conducted by investigators experienced in the treatment of paediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child appropriate language was provided and explained to the child. Repeated invasive procedures were minimised.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Jul 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Guatemala: 71
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Country: Number of subjects enrolled |
Argentina: 50
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Country: Number of subjects enrolled |
Peru: 50
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Country: Number of subjects enrolled |
Brazil: 188
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Country: Number of subjects enrolled |
Colombia: 110
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Country: Number of subjects enrolled |
Mexico: 158
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Worldwide total number of subjects |
627
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
338
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Children (2-11 years) |
289
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted at 30 centers in 6 countries. A total of 642 subjects were screened between 18 July 2014 and 30 December 2015. | ||||||||||||||||||
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Pre-assignment
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Screening details |
A total 642 subjects were screened, and 627 subjects were treated. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Arm title
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Bacillus clausii + ORT | ||||||||||||||||||
Arm description |
Bacillus clausii along with oral rehydration therapy (ORT) was given for 5 days. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Bacillus clausii
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Investigational medicinal product code |
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Other name |
Enterogermina™
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Vial containing 2 billion spores twice daily.
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Investigational medicinal product name |
ORT
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Investigational medicinal product code |
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Other name |
Enterolyte®
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Pharmaceutical forms |
Powder for oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
ORT (low osmolarity formulation) according to the Investigator's recommendation.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
Bacillus clausii along with ORT was given for 5 days. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Bacillus clausii + ORT
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Reporting group description |
Bacillus clausii along with oral rehydration therapy (ORT) was given for 5 days. | ||
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End point title |
Duration of Diarrhea [1] | ||||||||
End point description |
Duration of diarrhea, as counted from the first intake of the investigation product up to the first appearance of a loose stool followed by two consecutive normal stools. Analysis was performed on per-protocol (PP) population included all eligible subjects (not screen failure subjects) with no major protocol deviations.
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End point type |
Primary
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End point timeframe |
From Day 1 to Day 5
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This was not a comparative study (no inference was planned). Primary endpoint was provided only in terms of descriptive statistics. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean Number of Stools per Day | ||||||||||||||||||||
End point description |
Analysis was performed on PP population.
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End point type |
Secondary
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End point timeframe |
From Day 1 to Day 5
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Consistency of Stools | ||||||||||||||||||||||||||||||||||||||
End point description |
Analysis was performed on PP population.
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End point type |
Secondary
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End point timeframe |
From Day 1 to Day 5
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||
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End point title |
Number of Vomiting Episodes per Day | ||||||||||||||||||||
End point description |
Analysis was performed on PP population. Here, "n" signifies the subjects with data available at specified time point.
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End point type |
Secondary
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End point timeframe |
From Day 1 to Day 5
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Parent / Legal Guardian's Assessment of Children's Overall Acceptance of Enterogermina | ||||||||||||||||
End point description |
Children’s acceptance of enterogermina was recorded by their parents/legal guardian on a diary as: Excellent, good, fair, poor. Acceptance was assessed separately after both Dose 1 and Dose 2. Total percentage of subjects (assessed after dose 1 and dose 2) were reported. Analysis was performed on PP population.
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End point type |
Secondary
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End point timeframe |
From Day 1 to Day 5
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Parent / Legal Guardian's Assessment of Children's Overall General State | ||||||||||||||||||||||||||||||||||||||
End point description |
Children’s general state was recorded by their parents/legal guardian on a diary as: Good, fair and poor. Analysis was performed on PP population.
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End point type |
Secondary
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End point timeframe |
From Day 1 to Day 5
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
All Adverse Events (AE) were collected from signature of informed consent form up to final visit (between Day 6 and Day 10) regardless of seriousness or relationship to investigational product. Analysis was done on safety population.
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Adverse event reporting additional description |
Reported AE are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (first day of initial dose of study drug, up to the last visit).
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Assessment type |
Systematic | ||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
Bacillus clausii + ORT
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Reporting group description |
Bacillus clausii along with ORT was given for 5 days. | ||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events (equal or greater than threshold of 5%) were observed in any subjects during the study. |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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29 Jan 2014 |
Change in exclusion criteria to clarify the permission of probiotics and prebiotics in dairy food (such as yoghurt, cheese, milk) prior to study. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
