Effect of probiotics on multiple trauma patients

Effect of enteral probiotics on prognostic scores and C-reactive protein levels in critically ill multiple trauma patients: A double-blind placebo-controlled randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211006052684N1

Enrollment

Registered

2021-10-19

Start date

2021-10-23

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

Traumatic patients. Unspecified multiple injuries

Interventions

Intervention 1: Intervention group: Two Lactocare probiotic capsules from Zisttakhmir pharmaceuticals will be given to the intervention group every 12 hours for a total of 7 days. The route of adminis

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients who are admitted to the intensive care unit (ICU) due to trauma Patients older than 18 and younger than 70 years Patients who are expected to stay in the ICU for 7 days or more

Exclusion criteria

Exclusion criteria: Patients who do not consent to participate in the study. Patients who have absolute contraindication to enteral feeding or the use of probiotics. Pregnant patients Patients with an APACHE II score of more than 34 (mortality rate of 85% and higher)

Design outcomes

Primary

Measure	Time frame
Quantitative C-reactive protein (QCRP). Timepoint: Before and 7 days after the beginning of intervention. Method of measurement: Laboratory Kit.;The Acute Physiology and Chronic Health Evaluation II score (APACHE II). Timepoint: Before and 7 days after the beginning of intervention. Method of measurement: Based on the APACHE II score table.;The Simplified Acute Physiology Score (SAPS II). Timepoint: Before and 7 days after the beginning of intervention. Method of measurement: Based on the SAPS II score table.;Sequential Organ Failure Assessment (SOFA). Timepoint: Before and 7 days after the beginning of intervention. Method of measurement: Based on the SOFA score table.	—

Measure

Time frame

Quantitative C-reactive protein (QCRP). Timepoint: Before and 7 days after the beginning of intervention. Method of measurement: Laboratory Kit.;The Acute Physiology and Chronic Health Evaluation II score (APACHE II). Timepoint: Before and 7 days after the beginning of intervention. Method of measurement: Based on the APACHE II score table.;The Simplified Acute Physiology Score (SAPS II). Timepoint: Before and 7 days after the beginning of intervention. Method of measurement: Based on the SAPS II score table.;Sequential Organ Failure Assessment (SOFA). Timepoint: Before and 7 days after the beginning of intervention. Method of measurement: Based on the SOFA score table.

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Secondary

Measure	Time frame
28-day mortality. Timepoint: 28 days after the start of the intervention. Method of measurement: Questionnaire.;Time to discharge. Timepoint: At the time of patient discharge. Method of measurement: Total days from the start of intervention to discharge.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirhossein Akhavan Sigari

Esfahan University of Medical Sciences

amirsigari@aol.com+98 31 3668 8092

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 11, 2026