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Effect of early enteral feeding plus probiotic supplement on clinical outcome of severe traumatic brain injury: a randomized controlled double blind study

Effect of early enteral feeding plus probiotic supplement on clinical outcome of severe traumatic brain injury: a randomized controlled double blind study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202606490129030
Enrollment
54
Registered
2026-06-01
Start date
2023-01-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Nervous System Diseases

Interventions

A placebo 20mls of water for injection
Multispecies probiotic tablets

Sponsors

University of Ilorin Teaching Hospital
Lead Sponsor
University of Ilorin Teaching Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients aged 18 years and above with severe traumatic brain injury who were admitted within 24 hours of the traumatic event, whose care givers consented to the study.

Exclusion criteria

Exclusion criteria: 1. Patients less than 18years of age. 2. Patients with features suggestive of basal skull fracture (anterior basal fracture) were excluded in order to prevent inadvertent passage of the nasogastric tube into the cranial cavity. 3. Patients with history suggestive of immunocompromise i.e. poorly controlled diabetes mellitus, HIV, prolonged steroid use, chronic kidney disease or liver cirrhosis. 4. Pregnant patients. 5. Patients who died within 24 hours of admission 6. Polytraumatized patients i.e patients with history suggestive of concomitant spinal cord injury, blunt or penetrating abdominal injury, chest trauma or skeletal injuries. 7. Patients with a previous history of use of probiotics.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure in this study was the Glasgow Outcome Score Extended (GOS-E) in both the intervention and control groups

Secondary

MeasureTime frame
1. The mean number of days taken to tolerate enteral feeding fully in each group. 2. The mean length of ICU stay of patients in each group. 3. The mean length of hospital stay of patients in each group. 4. The 30-day mortality in each group.

Countries

Nigeria

Contacts

Public ContactOlukorede Adekunle

Consultant Neurosurgeon University of Ilorin Teaching Hospital

adekunleolukorede@gmail.com+2347081467138

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026