Saccharomyces boulardii for the PREvention of Antibiotic-associated and Clostridium difficile-associated Diarrhoea in adult hospitalised patients
| ISRCTN | ISRCTN86623192 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86623192 |
| EudraCT/CTIS number | 2008-001426-14 |
| Secondary identifying numbers | EudraCT 2008-001426-14 |
- Submission date
- 04/03/2011
- Registration date
- 17/03/2011
- Last edited
- 08/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Pietro Pozzoni
Scientific
Scientific
Via dell'Eremo 9/11
Lecco
23900
Italy
| Phone | +39 (0)34 148 9670 |
|---|---|
| p.pozzoni@ospedale.lecco.it |
Study information
| Study design | Single-centre randomised double-blind placebo-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, the contact details to request a patient information sheet is: Agostino Colli Department of Medicine, A. Manzoni Hospital, Via dellEremo 9/11, 23900 Lecco, Italy phone : +39(0)34 148 9670 fax +39(0)34 148 9671 email: a.colli@ospedale.lecco.it |
| Scientific title | Saccharomyces boulardii for the prevention of antibiotic-associated and Clostridium difficile-associated diarrhoea in adult hospitalised patients: a single-centre, randomised, double-blind, placebo-controlled trial |
| Study acronym | PREDA |
| Study objectives | To test the effect of Saccharomyces boulardii on the occurrence of antibiotic-associated diarrhoea and Clostridium difficile-associated diarrhoea in hospitalised patients receiving antibiotics. |
| Ethics approval(s) | Ethics Committee of A. Manzoni Hospital, AO Provincia di Lecco approved on 2 April 2008 |
| Health condition(s) or problem(s) studied | Antibiotic-associated-diarrhoea, Clostridium difficile-associated diarrhoea |
| Intervention | Probiotic capsule, consisting of a lyophilised preparation containing 5 x 109 colony forming units of S. boulardii, twice daily, in fasting conditions, starting within 48 hours after the beginning of antibiotic therapy and continuing until 7 days after its discontinuation. The control group will be given placebo capsules, prepared by the hospital pharmacy, containing rice flour and with identical appearance, taste and smell as the probiotic capsules, according to the same time schedule. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Saccharomyces boulardii |
| Primary outcome measure | 1. Antibiotic-associated diarrhoea, defined as the presence of more than three passages of liquid stools per day for at least 2 days or at least five in less than 48 hours 2. Clostridium difficile-associated diarrhoea, defined as antibiotic-associated diarrhoea with positive testing for Clostridium difficile toxins A and/or B |
| Secondary outcome measures | 1. Mortality 2. Adverse effects |
| Overall study start date | 02/04/2009 |
| Completion date | 31/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | Eligible patients were those aged over 50 before to be given antibiotics or on antibiotic regimen for less than 48 hours, regardless of the number of antibiotic medications and route of administration, for the treatment of a proven or suspected infection or for prophylaxis. |
| Key exclusion criteria | 1. Diarrhoea accounting for hospital admission or on-going at the time of starting antibiotics 2. Regular intake of probiotics (assumed as specific products, thus excluding those mixed in dairy or other foods) in the period preceding the hospital admission 3. Inability or unwilling to give written informed consent 4. Inability to assume tablets orally or through naso-enteric tubes 5. On-going severe acute pancreatitis |
| Date of first enrolment | 02/04/2009 |
| Date of final enrolment | 31/07/2010 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via dell'Eremo 9/11
Lecco
23900
Italy
23900
Italy
Sponsor information
A. Manzoni Hospital, AO Provincia di Lecco (Italy)
Hospital/treatment centre
Hospital/treatment centre
Via dell'Eremo 9/11
Lecco
23900
Italy
| Phone | +39 (0)34 148 9670 |
|---|---|
| a.colli@ospedale.lecco.it | |
"ROR" |
https://ror.org/030kaa114 |
Funders
Funder type
Hospital/treatment centre
A. Manzoni Hospital, AO Provincia di Lecco (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2012 | Yes | No |
