RecruitingNot Applicable

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

United States35 participantsStarted 2023-10-15

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18-85 years of age
✓. diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2)
✓. classification of A, B, C (motor complete, incomplete).

Exclusion criteria

✕. Women who are pregnant prior to consent
✕. neurological impairment other than SCI
✕. self-reported history of Crohn's disease or diverticulitis
✕. irritable bowel syndrome
✕. gastric blockage/obstruction or swallowing disorder
✕. prior GI surgery
✕. intrathecal pump
✕. concurrent usage of functional electrical stimulation for bowel management (e.g., constipation).

What they're measuring

Neurological impairment - Injury level by ISNCSCI

Timeframe: Baseline

Neurological impairment - Injury level by AIS

Timeframe: Baseline

Neurological impairment - completeness of injury by ISNCSCI

Timeframe: Baseline

Neurological impairment - completeness of injury by AIS

Timeframe: Baseline

Neurological impairment - Injury level by ISNCSCI

Timeframe: Month 6

Neurological impairment - Injury level by AIS

Timeframe: Month 6

Neurological impairment - completeness of injury by ISNCSCI

Timeframe: Month 6

Neurological impairment - completeness of injury by AIS

Timeframe: Month 6

Trial details

NCT IDNCT05670288

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-01

Contact for this trial

Jereme Wilroy, PhD

(205) 934-0355 jdwilroy@uab.edu

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18-85 years of age
✓. diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2)
✓. classification of A, B, C (motor complete, incomplete).

Exclusion criteria

✕. Women who are pregnant prior to consent
✕. neurological impairment other than SCI
✕. self-reported history of Crohn's disease or diverticulitis
✕. irritable bowel syndrome
✕. gastric blockage/obstruction or swallowing disorder
✕. prior GI surgery
✕. intrathecal pump
✕. concurrent usage of functional electrical stimulation for bowel management (e.g., constipation).

What they're measuring

Neurological impairment - Injury level by ISNCSCI

Timeframe: Baseline

Neurological impairment - Injury level by AIS

Timeframe: Baseline

Neurological impairment - completeness of injury by ISNCSCI

Timeframe: Baseline

Neurological impairment - completeness of injury by AIS

Timeframe: Baseline

Neurological impairment - Injury level by ISNCSCI

Timeframe: Month 6

Neurological impairment - Injury level by AIS

Timeframe: Month 6

Neurological impairment - completeness of injury by ISNCSCI

Timeframe: Month 6

Neurological impairment - completeness of injury by AIS

Timeframe: Month 6