Influence of symbiotics in the outcome of multiple organ dysfunction syndrome

ISRCTN	ISRCTN22361317
DOI	https://doi.org/10.1186/ISRCTN22361317
Protocol serial number	FISCAM: PI-2007/13
Sponsor	Hospital Virgen de la Salud (Spain)
Funder	FISCAM Health Research Foundation (Spain) (ref.: PI-2007/13)

Submission date: 09/12/2008
Registration date: 16/01/2009
Last edited: 16/01/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ismael López de Toro Martín-Consuegra
Scientific

Avda. Barber, 30
Intensive Care Unit
Hospital V. de la Salud
Toledo
45005
Spain

Phone	+34 925 26 92 37
Email	ilopez@sescam.jccm.es

Study information

Primary study design	Interventional
Study design	Single-centre prospective aleatorised randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Influence of symbiotics in the outcome of multiple organ dysfunction syndrome: a prospective, aleatorised, randomised controlled trial
Study objectives	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(s)	Clinical Investigation Ethics Committee of Hospital "Virgen de la Salud" (Toledo, Spain) gave approval on 12th January 2008
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Priegola Simbiotic Drink®
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	350
Key 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.
Key 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
Date of first enrolment	01/12/2008
Date of final enrolment	01/12/2009

Locations

Countries of recruitment

Spain

Study participating centre

Avda. Barber, 30

Toledo
45005
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes