Influence of symbiotics in the outcome of multiple organ dysfunction syndrome

Influence of symbiotics in the outcome of multiple organ dysfunction syndrome: a prospective, aleatorised, randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN22361317

Enrollment

350

Registered

2009-01-16

Start date

2008-12-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple organ dysfunction syndrome Not Applicable Multiple organ failure

Interventions

Intervention group: Priegola Simbiotic Drink®, a pasteurised milk, partially skimmed, with prebiotics (soluble fibre BENEO 1.5% [SYNERGY-1]) and probiotics (Streptococcus thermophilus, Lactobacillus

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026