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

Spinal Cord Injuries Clinical Trial

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

Status Recruiting

Clinical Trial Summary

The Investigators will recruit 50 participants with acute SCI (within 72 hours of injury) Fasting blood collection and bowel function survey will be conducted 4 times: at baseline [the time of first stool sample, within 72 hours of injury] and 1, 6, and 12 months after SCI. Stool will be collected for gut microbiome analysis 4 times

Clinical Trial Description

Stool and fasting blood collection will occur at the hospital (during in-patient stay) and at participants' homes. During the hospital stay, stool will be collected at the bedside by the research team and placed in a Para-pak® vial for sample preservation. Blood will also be collected by the research team.

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 and Twilio platform); 6)use of supplements and bowel routine components, including probiotics and laxatives (via self-report); and 7)any other comorbidities beyond GI dysfunction ;

Related Conditions & MeSH terms

• Gut Microbiome
• Spinal Cord Injuries
• Wounds and Injuries

• NCT number: NCT05670288
• Study type: Observational
• Source: University of Alabama at Birmingham
• Contact: Jereme Wilroy, PhD
• Phone: (205) 934-0355
• Email: jdwilroy@uab.edu
• Status: Recruiting
• Start date: October 15, 2023
• Completion date: February 28, 2027