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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05670288
Recruitment Status : Recruiting
First Posted : January 4, 2023
Last Update Posted : April 27, 2023
Sponsor:
Information provided by (Responsible Party):
Jereme Wilroy, University of Alabama at Birmingham

Study Description
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Brief 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

Condition or disease Intervention/treatment
Spinal Cord Injuries Gut Microbiome Other: Gut Microbiome

Detailed 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

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
Estimated Study Start Date : June 12, 2023
Estimated Primary Completion Date : December 1, 2026
Estimated Study Completion Date : February 28, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Spinal Cord Injury
Patients who have had an acute spinal cord injury in the past 72 hours
 Other: Gut Microbiome
Observe the changes in microbial community, such as bacteria, in the gut within the first year of spinal cord injury


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Stool and Blood

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have had an acute spinal cord injury in the past 72 hours.
Criteria

Inclusion Criteria:

  1. 18-65 years of age
  2. diagnosis of traumatic SCI at the cervical or thoracic level (C5-T6)
  3. classification of A, B (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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05670288


Contacts
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Contact: Jereme Wilroy, PhD (205) 934-0355 jdwilroy@uab.edu

Locations
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United States, Alabama
The University of Alabama at Birmingahm Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jereme Wilroy, PhD    205-934-0355    jdwilroy@uab.edu   
Principal Investigator: Jereme Wilroy, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Jereme Wilroy, PhD University of Alabama at Birmingham
More Information
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Responsible Party: Jereme Wilroy, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT05670288    
Other Study ID Numbers: IRB-300010011
First Posted: January 4, 2023    Key Record Dates
Last Update Posted: April 27, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jereme Wilroy, University of Alabama at Birmingham:
SCI
Inflammation
Bowel Function
Blood Sugar
Lipid Profiles
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System