Clinical trial NCT05670288: Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
Official title: Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injuries
Gut Microbiome
Keywords: SCI
Inflammation
Bowel Function
Blood Sugar
Lipid Profiles
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have had an acute spinal cord injury in the past 6 weeks.

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

1. 18-85 years of age
2. diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2)
3. classification of A, B, C (motor complete, incomplete).

Exclusion Criteria:

1. Women who are pregnant prior to consent
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

Primary outcomes:
measure: Neurological impairment - Injury level by ISNCSCI
timeFrame: Baseline
measure: Neurological impairment - Injury level by AIS
timeFrame: Baseline
measure: Neurological impairment - completeness of injury by ISNCSCI
timeFrame: Baseline
measure: Neurological impairment - completeness of injury by AIS
timeFrame: Baseline
measure: Neurological impairment - Injury level by ISNCSCI
timeFrame: Month 6
measure: Neurological impairment - Injury level by AIS
timeFrame: Month 6
measure: Neurological impairment - completeness of injury by ISNCSCI
timeFrame: Month 6
measure: Neurological impairment - completeness of injury by AIS
timeFrame: Month 6
measure: Neurological impairment - Injury level by ISNCSCI
timeFrame: Month 12
measure: Neurological impairment - Injury level by AIS
timeFrame: Month 12
measure: Neurological impairment - completeness of injury by ISNCSCI
timeFrame: Month 12
measure: Neurological impairment - completeness of injury by AIS
timeFrame: Month 12
measure: Microbiome composition - Bacterial 16S rRNA sequincing
timeFrame: Baseline
measure: Microbiome composition - Bacterial 16S rRNA sequincing
timeFrame: Month 1
measure: Microbiome composition - Bacterial 16S rRNA sequincing
timeFrame: Month 6
measure: Microbiome composition - Bacterial 16S rRNA sequincing
timeFrame: Month 12
measure: Microbiome composition - Metagenomics
timeFrame: Baseline
measure: Microbiome composition - Metagenomics
timeFrame: Month 1
measure: Microbiome composition - Metagenomics
timeFrame: Month 6
measure: Microbiome composition - Metagenomics
timeFrame: Month 12
measure: Gut derived metabolites
timeFrame: Baseline
measure: Gut derived metabolites
timeFrame: Month 1
measure: Gut derived metabolites
timeFrame: Month 6
measure: Gut derived metabolites
timeFrame: Month 12
measure: Analysis of metabolic markers to determine metabolic function
timeFrame: Baseline
measure: Analysis of metabolic markers to determine metabolic function
timeFrame: Month 1
measure: Analysis of metabolic markers to determine metabolic function
timeFrame: Month 6
measure: Analysis of metabolic markers to determine metabolic function
timeFrame: Month 12
measure: Analysis of inflammatory markers to determine Inflammatory state
timeFrame: Baseline
measure: Analysis of inflammatory markers to determine Inflammatory state
timeFrame: Month 1
measure: Analysis of inflammatory markers to determine Inflammatory state
timeFrame: Month 6
measure: Analysis of inflammatory markers to determine Inflammatory state
timeFrame: Month 12
measure: Bowel function - International Bowel Function Basic and Extended Data Set Assessment
timeFrame: Baseline
measure: Bowel function - Bristol Stool Scale
timeFrame: Baseline
measure: Bowel function - International Bowel Function Basic and Extended Data Set Assessment
timeFrame: Month 1
measure: Bowel function - Bristol Stool Scale
timeFrame: Month 1
measure: Bowel function - International Bowel Function Basic and Extended Data Set Assessment
timeFrame: Month 6
measure: Bowel function - Bristol Stool Scale
timeFrame: Month 6
measure: Bowel function - International Bowel Function Basic and Extended Data Set Assessment
timeFrame: Month 12
measure: Bowel function - Bristol Stool Scale
timeFrame: Month 12
Secondary outcomes:
measure: Diet
timeFrame: Baseline
measure: Diet
timeFrame: Month 1
measure: Diet
timeFrame: Month 6
measure: Diet
timeFrame: Month 12
measure: Physical activity - PARA-SCI
timeFrame: Baseline
measure: Physical activity - CDEs
timeFrame: Baseline
measure: Physical activity - PARA-SCI
timeFrame: Month 1
measure: Physical activity - CDEs
timeFrame: Month 1
measure: Physical activity - PARA-SCI
timeFrame: Month 6
measure: Physical activity - CDEs
timeFrame: Month 6
measure: Physical activity - PARA-SCI
timeFrame: Month 12
measure: Physical activity - CDEs
timeFrame: Month 12
measure: Medication List - Medical Record Review
timeFrame: Baseline
measure: Medication List - Self-report
timeFrame: Baseline
measure: Medication List - Medical Record Review
timeFrame: Month 1
measure: Medication List - Self-report
timeFrame: Month 1
measure: Medication List - Medical Record Review
timeFrame: Month 6
measure: Medication List - Self-report
timeFrame: Month 6
measure: Medication List - Medical Record Review
timeFrame: Month 12
measure: Medication List - Self-report
timeFrame: Month 12
measure: Supplement usage - Medical Record Review
timeFrame: Baseline
measure: Supplement usage - self-report
timeFrame: Baseline
measure: Supplement usage - Medical Record Review
timeFrame: Month 1
measure: Supplement usage - self-report
timeFrame: Month 1
measure: Supplement usage - Medical Record Review
timeFrame: Month 6
measure: Supplement usage - self-report
timeFrame: Month 6
measure: Supplement usage - Medical Record Review
timeFrame: Month 12
measure: Supplement usage - self-report
timeFrame: Month 12
measure: Depression
timeFrame: Baseline
measure: Depression
timeFrame: Month 1
measure: Depression
timeFrame: Month 6
measure: Depression
timeFrame: Month 12
measure: Anxiety
timeFrame: Baseline
measure: Anxiety
timeFrame: Month 1
measure: Anxiety
timeFrame: Month 6
measure: Anxiety
timeFrame: Month 12
measure: Comorbidities
timeFrame: Baseline
measure: Comorbidities
timeFrame: Month 1
measure: Comorbidities
timeFrame: Month 6
measure: Comorbidities
timeFrame: Month 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingahm
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jereme Wilroy, PhD
role: PRINCIPAL_INVESTIGATOR
References: