Condition category
Not Applicable
Date applied
09/12/2008
Date assigned
16/01/2009
Last edited
16/01/2009
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 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

Publication citations

Additional files

Editorial Notes