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NCT Number: NCT05670288

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Gut Microbiome Inflammation Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Alabama at Birmingahm

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Jereme Wilroy, PhD

CONTACT

[email protected]

(205) 934-0355

Jereme Wilroy, PhD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Neurological impairment - Injury level by ISNCSCI

    Time frame: Baseline

    Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam

  2. Neurological impairment - Injury level by AIS

    Time frame: Baseline

    Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.

  3. Neurological impairment - completeness of injury by ISNCSCI

    Time frame: Baseline

    Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam

  4. Neurological impairment - completeness of injury by AIS

    Time frame: Baseline

    Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.

  5. Neurological impairment - Injury level by ISNCSCI

    Time frame: Month 6

    Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam

  6. Neurological impairment - Injury level by AIS

    Time frame: Month 6

    Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.

  7. Neurological impairment - completeness of injury by ISNCSCI

    Time frame: Month 6

    Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam

  8. Neurological impairment - completeness of injury by AIS

    Time frame: Month 6

    Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.

  9. Neurological impairment - Injury level by ISNCSCI

    Time frame: Month 12

    Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam

  10. Neurological impairment - Injury level by AIS

    Time frame: Month 12

    Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.

  11. Neurological impairment - completeness of injury by ISNCSCI

    Time frame: Month 12

    Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam

  12. Neurological impairment - completeness of injury by AIS

    Time frame: Month 12

    Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.

  13. Microbiome composition - Bacterial 16S rRNA sequincing

    Time frame: Baseline

    Bacterial 16S rRNA sequencing will be performed

  14. Microbiome composition - Bacterial 16S rRNA sequincing

    Time frame: Month 1

    Bacterial 16S rRNA sequencing will be performed

  15. Microbiome composition - Bacterial 16S rRNA sequincing

    Time frame: Month 6

    Bacterial 16S rRNA sequencing will be performed

  16. Microbiome composition - Bacterial 16S rRNA sequincing

    Time frame: Month 12

    Bacterial 16S rRNA sequencing will be performed

  17. Microbiome composition - Metagenomics

    Time frame: Baseline

    A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.

  18. Microbiome composition - Metagenomics

    Time frame: Month 1

    A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.

  19. Microbiome composition - Metagenomics

    Time frame: Month 6

    A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.

  20. Microbiome composition - Metagenomics

    Time frame: Month 12

    A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.

  21. Gut derived metabolites

    Time frame: Baseline

    Blood will be collected and serum extract metabolites will be isolated

  22. Gut derived metabolites

    Time frame: Month 1

    Blood will be collected and serum extract metabolites will be isolated

  23. Gut derived metabolites

    Time frame: Month 6

    Blood will be collected and serum extract metabolites will be isolated

  24. Gut derived metabolites

    Time frame: Month 12

    Blood will be collected and serum extract metabolites will be isolated

  25. Analysis of metabolic markers to determine metabolic function

    Time frame: Baseline

    Blood will be collected and serum assays for metabolic markers performed

  26. Analysis of metabolic markers to determine metabolic function

    Time frame: Month 1

    Blood will be collected and serum assays for metabolic markers performed

  27. Analysis of metabolic markers to determine metabolic function

    Time frame: Month 6

    Blood will be collected and serum assays for metabolic markers performed

  28. Analysis of metabolic markers to determine metabolic function

    Time frame: Month 12

    Blood will be collected and serum assays for metabolic markers performed

  29. Analysis of inflammatory markers to determine Inflammatory state

    Time frame: Baseline

    Blood will be collected and serum assays for inflammatory markers performed

  30. Analysis of inflammatory markers to determine Inflammatory state

    Time frame: Month 1

    Blood will be collected and serum assays for inflammatory markers performed

  31. Analysis of inflammatory markers to determine Inflammatory state

    Time frame: Month 6

    Blood will be collected and serum assays for inflammatory markers performed

  32. Analysis of inflammatory markers to determine Inflammatory state

    Time frame: Month 12

    Blood will be collected and serum assays for inflammatory markers performed

  33. Bowel function - International Bowel Function Basic and Extended Data Set Assessment

    Time frame: Baseline

    International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.

  34. Bowel function - Bristol Stool Scale

    Time frame: Baseline

    Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.

  35. Bowel function - International Bowel Function Basic and Extended Data Set Assessment

    Time frame: Month 1

    International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.

  36. Bowel function - Bristol Stool Scale

    Time frame: Month 1

    Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.

  37. Bowel function - International Bowel Function Basic and Extended Data Set Assessment

    Time frame: Month 6

    International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.

  38. Bowel function - Bristol Stool Scale

    Time frame: Month 6

    Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.

  39. Bowel function - International Bowel Function Basic and Extended Data Set Assessment

    Time frame: Month 12

    International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.

  40. Bowel function - Bristol Stool Scale

    Time frame: Month 12

    Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.

Secondary outcomes

  1. Diet

    Time frame: Baseline

    Participant records 24-hour dietary recalls

  2. Diet

    Time frame: Month 1

    Participant records 24-hour dietary recalls

  3. Diet

    Time frame: Month 6

    Participant records 24-hour dietary recalls

  4. Diet

    Time frame: Month 12

    Participant records 24-hour dietary recalls

  5. Physical activity - PARA-SCI

    Time frame: Baseline

    Complete PARA-SCI questionnaire to determine physical activity level

  6. Physical activity - CDEs

    Time frame: Baseline

    Complete rehabilitation therapies survey (CDEs) to determine physical activity level

  7. Physical activity - PARA-SCI

    Time frame: Month 1

    Complete PARA-SCI questionnaire to determine physical activity level

  8. Physical activity - CDEs

    Time frame: Month 1

    Complete rehabilitation therapies survey (CDEs) to determine physical activity level

  9. Physical activity - PARA-SCI

    Time frame: Month 6

    Complete PARA-SCI questionnaire to determine physical activity level

  10. Physical activity - CDEs

    Time frame: Month 6

    Complete rehabilitation therapies survey (CDEs) to determine physical activity level

  11. Physical activity - PARA-SCI

    Time frame: Month 12

    Complete PARA-SCI questionnaire to determine physical activity level

  12. Physical activity - CDEs

    Time frame: Month 12

    Complete rehabilitation therapies survey (CDEs) to determine physical activity level

  13. Medication List - Medical Record Review

    Time frame: Baseline

    Medical record review of prescribed medications being taken

  14. Medication List - Self-report

    Time frame: Baseline

    Self-report of prescribed medications being taken

  15. Medication List - Medical Record Review

    Time frame: Month 1

    Medical record review of prescribed medications being taken

  16. Medication List - Self-report

    Time frame: Month 1

    Self-report of prescribed medications being taken

  17. Medication List - Medical Record Review

    Time frame: Month 6

    Medical record review of prescribed medications being taken

  18. Medication List - Self-report

    Time frame: Month 6

    Self-report of prescribed medications being taken

  19. Medication List - Medical Record Review

    Time frame: Month 12

    Medical record review of prescribed medications being taken

  20. Medication List - Self-report

    Time frame: Month 12

    Self-report of prescribed medications being taken

  21. Supplement usage - Medical Record Review

    Time frame: Baseline

    Medical record review of supplements being taken

  22. Supplement usage - self-report

    Time frame: Baseline

    Self-report of supplements being taken

  23. Supplement usage - Medical Record Review

    Time frame: Month 1

    Medical record review of supplements being taken

  24. Supplement usage - self-report

    Time frame: Month 1

    Self-report of supplements being taken

  25. Supplement usage - Medical Record Review

    Time frame: Month 6

    Medical record review of supplements being taken

  26. Supplement usage - self-report

    Time frame: Month 6

    Self-report of supplements being taken

  27. Supplement usage - Medical Record Review

    Time frame: Month 12

    Medical record review of supplements being taken

  28. Supplement usage - self-report

    Time frame: Month 12

    Self-report of supplements being taken

  29. Depression

    Time frame: Baseline

    Complete PHQ9 questionnaires to determine depression level

  30. Depression

    Time frame: Month 1

    Complete PHQ9 questionnaires to determine depression level

  31. Depression

    Time frame: Month 6

    Complete PHQ9 questionnaires to determine depression level

  32. Depression

    Time frame: Month 12

    Complete PHQ9 questionnaires to determine depression level

  33. Anxiety

    Time frame: Baseline

    Complete GAD7 questionnaire to determine anxiety level

  34. Anxiety

    Time frame: Month 1

    Complete GAD7 questionnaire to determine anxiety level

  35. Anxiety

    Time frame: Month 6

    Complete GAD7 questionnaire to determine anxiety level

  36. Anxiety

    Time frame: Month 12

    Complete GAD7 questionnaire to determine anxiety level

  37. Comorbidities

    Time frame: Baseline

    Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction

  38. Comorbidities

    Time frame: Month 1

    Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction

  39. Comorbidities

    Time frame: Month 6

    Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction

  40. Comorbidities

    Time frame: Month 12

    Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction

Study contacts

Contact information is provided by the study sponsor or research team.

Jereme Wilroy, PhD

CONTACT

[email protected]

(205) 934-0355

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Craig Hospital
  • Rancho Los Amigos National Rehabilitation Center
  • University of Pittsburgh Medical Center

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 4, 2023
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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