Skip to content

The effect of probiotics and synbiotics in brain trauma.

Surveying of the Effect of Probiotic and Synbiotic Supplementation in Patients with Traumatic Brain Injury.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250125064510N2
Enrollment
105
Registered
2025-04-18
Start date
2025-05-22
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Trauma brain injury. Diffuse traumatic brain injury

Interventions

Intervention 1: Intervention group: The first intervention group received a probiotic supplement containing 1×109 CFU of probiotic organisms for 10 days from Tekgen Zist Company. Intervention 2: Inter

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of brain trauma with CT scan and diagnosis by a specialist Diagnosis of severe brain trauma with a Glasgow Coma Scale between 3 and 8 Age 18 to 70 years Need for at least ten days of hospitalization in the intensive care unit with the diagnosis and prognosis of the relevant specialist Patient's hemodynamic stability

Exclusion criteria

Exclusion criteria: Pregnancy or lactation Previous major gastrointestinal; hematological; endocrine diseases; Immunosuppression; Pneumonia or other infectious diseases after admission; HIV positivity; cancer Use of probiotic or synbiotic supplements within the last month prior to study entry

Design outcomes

Primary

MeasureTime frame
C-reactive protein. Timepoint: Beginning of the study and the tenth day of the study. Method of measurement: Enzyme-linked immunosorbent assay.;Interleukin 6. Timepoint: Beginning of the study and the tenth day of the study. Method of measurement: Enzyme-linked immunosorbent assay.

Secondary

MeasureTime frame
Erythrocyte sedimentation rate. Timepoint: Beginning of the study and the tenth day of the study. Method of measurement: Westergren.;Assessing the level of consciousness. Timepoint: Beginning of the study and the tenth day of the study. Method of measurement: Glasgow Coma Scale.;Disease severity score. Timepoint: Beginning of the study and the tenth day of the study. Method of measurement: Acute Physiology and Chronic Health Evaluation II (APACHE II).;Organ failure in the intensive care unit. Timepoint: Beginning of the study and the tenth day of the study. Method of measurement: Sequential Organ Failure Assessment score (SOFA score).;Length of hospital stay. Timepoint: Study start and discharge time. Method of measurement: Patient file.;Mortality. Timepoint: 30 days after receiving interventions. Method of measurement: The discharge status of the patient as well as telephone follow-up 28days after receiving the intervention.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mohammad Aghaeinejad

Iran University of Medical Sciences

m.aqaei@yahoo.com0098 21 64351

Outcome results

None listed

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