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Recruiting NCT05670288

Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury

◆ AI Clinical Summary

This study examines how bacteria in the gut may affect metabolism and bowel function during the first year after a spinal cord injury. Participants will provide blood and stool samples at baseline, 6 months, and 12 months after their injury to help researchers understand these connections.

Key Objective: This trial aims to identify how gut microbiome changes after spinal cord injury might influence metabolic health and bowel function, potentially leading to better management strategies.

Who to Consider: People who have experienced a spinal cord injury within the past 6 weeks and are interested in contributing to research that may improve long-term health outcomes after SCI should consider enrolling.

Trial Parameters

Condition Spinal Cord Injuries
Sponsor University of Alabama at Birmingham
Study Type OBSERVATIONAL
Phase N/A
Enrollment 35
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2023-10-15
Completion 2026-12-01

Brief Summary

The Investigators will recruit 35 participants with acute SCI (within 6 weeks of injury) Fasting blood collection and bowel function survey will be conducted 3 times: at baseline \[within 6 weeks of injury\], 6, and 12 months after SCI. Stool will be collected for gut microbiome analysis 3 times.

Eligibility Criteria

Inclusion Criteria: 1. 18-85 years of age 2. diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2) 3. classification of A, B, C (motor complete, incomplete). Exclusion Criteria: 1. Women who are pregnant prior to consent 2. neurological impairment other than SCI 3. self-reported history of Crohn's disease or diverticulitis 4. irritable bowel syndrome 5. gastric blockage/obstruction or swallowing disorder 6. prior GI surgery 7. intrathecal pump 8. concurrent usage of functional electrical stimulation for bowel management (e.g., constipation). 9. able to ambulate

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