Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
NCT ID: NCT05670288
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
35 participants
OBSERVATIONAL
2023-10-15
2027-02-28
Brief Summary
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Detailed Description
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For sample collection at home, a research nurse will travel to participants home to perform blood draws and bing back to the research lab for processing/analysis/storage.
The nurse may also collect the stool sample at the same time as the blood draw if available. If not, participants and their caregivers will be provided with a pre-paid/labeled FedEx package containing a stool collection kit (Para-pak® vial). Prior to bowel movement, participants and caregivers will be asked to clean the anal area using the sanitizing wipes; approximately 5-10 mL of stool will be transferred to the Para-pak® vial using the attached spatula in the Para-pak® vial. For participants who conduct their bowel management program in their beds, an additional sterile absorbent pad will be provided to use as a barrier between the bed and the participant to limit contamination. FedEx package containing the stool sample will be shipped to the investigators' lab
For each participant, the Investigators will record 1) diet (via 24-hour dietary recalls), 2) physical activity habits (via the rehabilitation therapies survey included in the SCI common data elements \[CDEs\], 3)Leisure Time Physical Activity Questionnaire; 4)depression and anxiety (via Patient Health Questionnaire-9 \[PHQ9\] and the General Anxiety Disorder-7 scale (GAD7),respectively); 5)prescribed medications, including antibiotics (via RedCap platform); 6)use of supplements and bowel routine components, including probiotics and laxatives (via self-report); and 7)any other comorbidities beyond GI dysfunction
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Spinal Cord Injury
Patients who have had an acute spinal cord injury in the past 72 hours
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2)
3. classification of A, B, C (motor complete, incomplete).
Exclusion Criteria
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
18 Years
85 Years
ALL
No
Sponsors
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University of Pittsburgh Medical Center
OTHER
Craig Hospital
OTHER
Rancho Los Amigos National Rehabilitation Center
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Jereme Wilroy
Associate Professor
Principal Investigators
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Jereme Wilroy, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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The University of Alabama at Birmingahm
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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90SIMS0020
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB-300010011
Identifier Type: -
Identifier Source: org_study_id