Clinical Trial Results:
A double blind placebo controlled randomised clinical trial to study the effect of Probiotics for the prevetion or amelioration of Antibiotic Associated Diarrhoea in residents of care homes in South Wales and England
Summary
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EudraCT number |
2011-006269-17 |
Trial protocol |
GB |
Global end of trial date |
31 Oct 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Mar 2020
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First version publication date |
29 Mar 2020
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Other versions |
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Summary report(s) |
PAADII - cancelled before active statement |
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 |
SPON1069-11
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Additional study identifiers
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ISRCTN number |
ISRCTN25324586 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Cardiff University
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Sponsor organisation address |
Mckenzie House, Cardiff, United Kingdom,
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Public contact |
Julia Townson, South East Wales Trials Unit (SEWTU), Cardiff University, 44 02920687606, townson@cf.ac.uk
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Scientific contact |
Julia Townson, South East Wales Trials Unit (SEWTU), Cardiff University, 44 02920687606, townson@cf.ac.uk
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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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Oct 2013
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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 |
31 Oct 2013
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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 compare the effect of probiotics vs placebo, taken in conjunction with antibiotics, on the incidence of (AAD) in care home service users
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Protection of trial subjects |
n/a
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Oct 2012
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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 |
United Kingdom: 99999
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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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) |
0
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Children (2-11 years) |
0
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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 |
99999
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85 years and over |
0
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Recruitment
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Recruitment details |
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial. | ||||||
Pre-assignment
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Screening details |
One sachet (4.4g of freeze-dried powder), twice daily | ||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
n/a
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Arms
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Arm title
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Probiotic | ||||||
Arm description |
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
VSL#3
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral powder in sachet
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Routes of administration |
Oral use
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Dosage and administration details |
One sachet (4.4g of freeze-dried powder), twice daily
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial (overall period)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Probiotic
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Reporting group description |
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial. |
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End point title |
at least one episode of AAD [1] | ||||||
End point description |
99999 is "not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial
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End point type |
Primary
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End point timeframe |
n/a
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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: 99999 is "not applicable" value or 0 participants, this trial was discontinued with no participants. No statistical analyses for this end point. |
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Notes [2] - 99999 is "not applicable" value or 0 participants, this trial was discontinued with no participants |
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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 |
n/a 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
0
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Frequency threshold for reporting non-serious adverse events: 0% | |||
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: 99999 is "not applicable" value or 0 participants, this trial was discontinued with no participants. No adverse events to report. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
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. | |||
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial. |