Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries, Gut Microbiome. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Stool and fasting blood collection will occur at the rehabilitation 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 platform); 6)use of supplements and bowel routine components, including probiotics and laxatives (via self-report); and 7)any other comorbidities beyond GI dysfunction
Primary outcome measures
- Neurological impairment - Injury level by ISNCSCI [Time frame: Baseline]
- Neurological impairment - Injury level by AIS [Time frame: Baseline]
- Neurological impairment - completeness of injury by ISNCSCI [Time frame: Baseline]
- Neurological impairment - completeness of injury by AIS [Time frame: Baseline]
- Neurological impairment - Injury level by ISNCSCI [Time frame: Month 6]
- Neurological impairment - Injury level by AIS [Time frame: Month 6]
- Neurological impairment - completeness of injury by ISNCSCI [Time frame: Month 6]
- Neurological impairment - completeness of injury by AIS [Time frame: Month 6]
- Neurological impairment - Injury level by ISNCSCI [Time frame: Month 12]
- Neurological impairment - Injury level by AIS [Time frame: Month 12]
Secondary outcome measures (12)
- Diet [Time frame: Baseline]
- Diet [Time frame: Month 1]
- Diet [Time frame: Month 6]
- Diet [Time frame: Month 12]
- Physical activity - PARA-SCI [Time frame: Baseline]
- Physical activity - CDEs [Time frame: Baseline]
- Physical activity - PARA-SCI [Time frame: Month 1]
- Physical activity - CDEs [Time frame: Month 1]
- Physical activity - PARA-SCI [Time frame: Month 6]
- Physical activity - CDEs [Time frame: Month 6]
- Physical activity - PARA-SCI [Time frame: Month 12]
- Physical activity - CDEs [Time frame: Month 12]
Eligibility criteria
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).
- able to ambulate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- The University of Alabama at Birmingahm — Birmingham
Identifiers
NCT: NCT05670288 · IRB-300010011 · 90SIMS0020