Condition category
Infections and Infestations
Date applied
04/03/2011
Date assigned
17/03/2011
Last edited
08/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pietro Pozzoni

ORCID ID

Contact details

Via dell'Eremo 9/11
Lecco
23900
Italy
+39 (0)34 148 9670
p.pozzoni@ospedale.lecco.it

Additional identifiers

EudraCT number

2008-001426-14

ClinicalTrials.gov number

Protocol/serial number

EudraCT 2008-001426-14

Study information

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

Acronym

PREDA

Study hypothesis

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

Ethics Committee of A. Manzoni Hospital, AO Provincia di Lecco approved on 2 April 2008

Study design

Single-centre randomised double-blind placebo-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient 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 dell’Eremo 9/11,
23900 Lecco,
Italy
phone : +39(0)34 148 9670
fax +39(0)34 148 9671
email: a.colli@ospedale.lecco.it

Condition

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

Phase

Not Applicable

Drug names

Saccharomyces boulardii

Primary outcome measures

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 trial start date

02/04/2009

Overall trial end date

31/07/2010

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant 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

Recruitment start date

02/04/2009

Recruitment end date

31/07/2010

Locations

Countries of recruitment

Italy

Trial participating centre

Via dell'Eremo 9/11
Lecco
23900
Italy

Sponsor information

Organisation

A. Manzoni Hospital, AO Provincia di Lecco (Italy)

Sponsor details

Via dell'Eremo 9/11
Lecco
23900
Italy
+39 (0)34 148 9670
a.colli@ospedale.lecco.it

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

A. Manzoni Hospital, AO Provincia di Lecco (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22472744

Publication citations

  1. Results

    Pozzoni P, Riva A, Bellatorre AG, Amigoni M, Redaelli E, Ronchetti A, Stefani M, Tironi R, Molteni EE, Conte D, Casazza G, Colli A, Saccharomyces boulardii for the prevention of antibiotic-associated diarrhea in adult hospitalized patients: a single-center, randomized, double-blind, placebo-controlled trial., Am. J. Gastroenterol., 2012, 107, 6, 922-931, doi: 10.1038/ajg.2012.56.

Additional files

Editorial Notes