Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorUniversity of Alabama at Birmingham
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Women who are pregnant prior to consent
neurological impairment other than SCI
self-reported history of Crohn's disease or diverticulitis
irritable bowel syndrome
Trial population
Patients who have had an acute spinal cord injury in the past 6 weeks.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
35 Participants
are grouped into 1 trial groupGroup A: Spinal Cord Injury
Trial outcomes
Primary outcomes
1
Neurological impairment - Injury level by ISNCSCI
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Time frame
Baseline2
Neurological impairment - Injury level by AIS
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Time frame
Baseline3
Neurological impairment - completeness of injury by ISNCSCI
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Time frame
Baseline4
Neurological impairment - completeness of injury by AIS
Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Time frame
BaselineSecondary outcomes
1
Diet
Participant records 24-hour dietary recalls
Time frame
Baseline2
Diet
Participant records 24-hour dietary recalls
Time frame
Month 13
Diet
Participant records 24-hour dietary recalls
Time frame
Month 64
Diet
Participant records 24-hour dietary recalls
Time frame
Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
University of Pittsburgh Medical Center
Collaborator
Craig Hospital
Collaborator
Rancho Los Amigos National Rehabilitation Center
Collaborator
Source ClinicalTrials.gov