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The effect of synbiotic supplementation on patients with multiple trauma injuries provided there is brain trauma

The effects of synbiotics supplementation on inflammatory, liver, blood sugar, kidney and oxidative stress biomarkers and clinical clinical indicators in patients with multiple trauma injury , under the condition of having a brain trauma admitted to the intensive care unit (ICU) A double-blind randomized clinical controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241109063642N1
Enrollment
60
Registered
2024-11-18
Start date
2024-12-20
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Multiple trauma patients with brain trauma condition. Other specified injuries involving multiple body regions

Interventions

Intervention 1: Intervention group: 10 grams of biogen synbiotic from Tekgen Biot Company in the form of two 5-gram sachets twice a day along with gavage and observing at least 4 hours with antibiotic

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age 20-80 years Presence of brain damage Digestive system with normal function and intestinal nutrition standards Diagnosis of moderate or severe trauma based on the Glasgow Coma Scale (GCS) index (4-14) Diagnosis of trauma based on the Injury Severity Score (ISS) between minor and severe levels The possibility of enteral feeding in the first 48 hours of admission No history of underlying heart disease Patients who are hospitalized in the intensive care unit for more than 48 hours Patients who do not die within 12 hours of being admitted to the intensive care unit Patients who are indicated for enteral nutrition on the first day or are confirmed and predicted to be able to receive enteral nutrition in the future based on the diagnosis of the special care department. Absence (nausea, resistant vomiting, ileus, bowel obstruction, uncontrolled diarrhea (>500 ml/day), high output fistula (>500 ml/day), lack of bowel access, incomplete resuscitation and hemodynamic instability) Patients with BMI>18.5kg/m2 who are admitted to the intensive care unit. Patients who do not receive nutritional support through complete intravenous nutrition. Patients who do not have a history of underlying diseases such as diabetes, congenital and immune disorders, kidney and liver failure, and pancreatitis. Absence of pregnancy and breastfeeding Consent of the patient or his legal guardian. Patients can enter the study if they adhere to 80% or more of the synbiotic.

Exclusion criteria

Exclusion criteria: Lack of consent of the patient or the patient's family to continue the intervention. Receiving frequent blood from patients. Intolerance of enteral feeding The need for multiple surgeries that require fasting for more than 8 hours before and after the operation. Creating infectious processes, DIC (diffuse intravascular coagulation) and any inflammatory interactions that interfere with the intervention process. The need to fast for more than 8 hours for any reason. Elevation of kidney and liver indicators that indicate acute liver and kidney failure.

Design outcomes

Primary

MeasureTime frame
C-Reactive Protein (CRP). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Erythrocyte sedimentation rate (ESR). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Complete blood count (CBC). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Blood sugar. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Blood urea nitrogen. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Creatinine. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Total antioxidant capecity (TAC). Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Superoxide dismutase (SOD). Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Aspartate transaminase (AST). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Alanine transaminase (ALT). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Lactate dehydrogenase. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Creatine phosphokinase (CPK). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.

Secondary

MeasureTime frame
28-day mortality. Timepoint: end of the study. Method of measurement: Mathematical dividing the number of dead persons by the total number of persons using hospital records or telephone follow-up.;Hospitalization period. Timepoint: end of the study. Method of measurement: The length of hospitalization of people using hospital records.;SOFA score. Timepoint: At baseline and end of the study. Method of measurement: hospital records.;Glasgow Coma Scale ( GCS). Timepoint: At baseline and end of the study. Method of measurement: hospital records.;Acute Physiology and Chronic Health Evaluation II (APACHE II). Timepoint: At baseline and end of the study. Method of measurement: Questionnaire.;NUTRIC. Timepoint: At baseline and end of the study. Method of measurement: Questionnaire.;Serum albumin. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Low-density lipoprotein (LDL). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;High-density lipoprotein (HDL). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Cholesterol. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Triglycerides. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hassan Eftekhari

Shiraz University of Medical Sciences

eftekharim@sums.ac.ir+98 71 3725 1001

Outcome results

None listed

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