Contact information
Type
Scientific
Primary contact
Dr Ismael López de Toro Martín-Consuegra
ORCID ID
Contact details
Avda. Barber
30
Intensive Care Unit
Hospital V. de la Salud
Toledo
45005
Spain
+34 925 26 92 37
ilopez@sescam.jccm.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FISCAM: PI-2007/13
Study information
Scientific title
Influence of symbiotics in the outcome of multiple organ dysfunction syndrome: a prospective, aleatorised, randomised controlled trial
Acronym
Study hypothesis
Bacterial translocation in the gastrointestinal tract is a key physiopathological process in the development of some critically ill patient's injuries, such as nosocomial pneumonia or multiple organ dysfunction syndrome. The bacterial overgrowth increases gut wall permeability, with associated bacterial translocation into the portal circulation leading to the development of distant septic foci. Different procedures have been used to eliminate the potentially pathogenic organisms for example: selective digestive decontamination with prophylactic administration of topic and intravenous antibiotic. An alternative approach is to introduce non-pathogenic bacteria which can replace the bacteria eliminated by antibiotic therapy and on the other hand, competitively inhibit colonisation by pathogenic strains.
Our working hypothesis is based on non-pathogenic bacteria from ICU-admission of the patient with at least two organ failures improving the course of patient-ICU, ICU-stay and hospital stay and could also have a beneficial effect on new individual organ failures. We think the administration of non-pathogenic bacteria will keep the normal flora in the gastrointestinal tract and decrease the multiple organ dysfunction syndrome incidence in ICU-patients.
Ethics approval
Clinical Investigation Ethics Committee of Hospital "Virgen de la Salud" (Toledo, Spain) gave approval on 12th January 2008
Study design
Single-centre prospective aleatorised randomised controlled 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, please use the contact details below to request a patient information sheet
Condition
Multiple organ dysfunction syndrome
Intervention
Intervention group:
Priegola Simbiotic Drink®, a pasteurised milk, partially skimmed, with prebiotics (soluble fibre BENEO 1.5% [SYNERGY-1]) and probiotics (Streptococcus thermophilus, Lactobacillus bulgaricus, Lactobacillus casei, Lactobacillus acidophilus and Bifidobacterium). 100 ml every 12 hours, in the first twelve hours of the organ failures beginning (two or more), for a maximum of seven days.
Control group:
The control group will not receive the symbiotic.
The total duration of treatment in the interventional group will be a maximum of seven days from the organ failure beginning. If the patient is discharged from ICU before seven days (exitus, hospital room), the total number of days with symbiotics will be recorded. The total duration of follow-up for all arms will be for ICU-stay and the following will be recorded:
1. Days of ICU stay
2. Days of hospital stay
3. Mortality intra-ICU
4. Intra-hospital stay
5. Post-hospital discharge
Intervention type
Drug
Phase
Not Applicable
Drug names
Priegola Simbiotic Drink®
Primary outcome measures
1. Decrease in hospital stay: days of ICU stay and hospital stay will be assessed
2. Decrease of time and number of injured organs:
2.1. Time of each organ failure and number of these will be assessed
2.2. Sequential Organ Failure Assessment (SOFA) classification will be applied to define the dysfunction of each organ
Secondary outcome measures
1. Decrease of 30 day-mortality: assessed exitus (yes/no) inside UCI, post-hospital discharge and 30 days after hospital discharge
2. Decrease of the bloodstream infections, taking into account only the samples confirmed by the microbiology laboratory
3. Decrease of the nosocomial pneumonia, assessing the nosocomial pneumonia diagnosed by the attending clinician
4. Improvement of tolerance to enteral nutrition: the number of days the patient can feed with enteral nutrition only
Overall trial start date
01/12/2008
Overall trial end date
01/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Adults (greater than 18 years, either sex) with two or more organ failures without exclusion criteria. The informed consent will be obtained from patients or their relatives.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
175 patients by group (total: 350)
Participant exclusion criteria
1. Less than 18 years
2. Pregnant
3. Severe immunodepression (neutropenia less than 500/ml)
4. Inability to receive symbiotic administration
5. Pancreatitis
6. Symbiotics allergy
7. Death in the first 12 hours
8. Patients taking part in another clinical trial
Recruitment start date
01/12/2008
Recruitment end date
01/12/2009
Locations
Countries of recruitment
Spain
Trial participating centre
Avda. Barber, 30
Toledo
45005
Spain
Sponsor information
Organisation
Hospital Virgen de la Salud (Spain)
Sponsor details
Intensive Care Unit
Avda. Barber
30
Toledo
45005
Spain
+34 925 26 92 37
ilopez@sescam.jccm.es
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
FISCAM Health Research Foundation (Spain) (ref.: PI-2007/13)
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