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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05670288
• Other study ID #: IRB-300010011
• Status: Recruiting
• Start date: October 15, 2023
• Est. completion date: February 28, 2027

Study information

• Verified date: October 2023
• Source: University of Alabama at Birmingham
• Contact: Jereme Wilroy, PhD
• Phone: (205) 934-0355
• Email: jdwilroy[@]uab.edu
• Is FDA regulated: No
• Study type: Observational

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 28, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Gut Microbiome
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Gut Microbiome
Observe the changes in microbial community, such as bacteria, in the gut within the first year of spinal cord injury

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingahm	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological impairment - Injury level by ISNCSCI	Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam	Baseline
Primary	Neurological impairment - Injury level by AIS	Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.	Baseline
Primary	Neurological impairment - completeness of injury by ISNCSCI	Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam	Baseline
Primary	Neurological impairment - completeness of injury by AIS	Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.	Baseline
Primary	Neurological impairment - Injury level by ISNCSCI	Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam	Month 6
Primary	Neurological impairment - Injury level by AIS	Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.	Month 6
Primary	Neurological impairment - completeness of injury by ISNCSCI	Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam	Month 6
Primary	Neurological impairment - completeness of injury by AIS	Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.	Month 6
Primary	Neurological impairment - Injury level by ISNCSCI	Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam	Month 12
Primary	Neurological impairment - Injury level by AIS	Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.	Month 12
Primary	Neurological impairment - completeness of injury by ISNCSCI	Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam	Month 12
Primary	Neurological impairment - completeness of injury by AIS	Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.	Month 12
Primary	Microbiome composition - Bacterial 16S rRNA sequincing	Bacterial 16S rRNA sequencing will be performed	Baseline
Primary	Microbiome composition - Bacterial 16S rRNA sequincing	Bacterial 16S rRNA sequencing will be performed	Month 1
Primary	Microbiome composition - Bacterial 16S rRNA sequincing	Bacterial 16S rRNA sequencing will be performed	Month 6
Primary	Microbiome composition - Bacterial 16S rRNA sequincing	Bacterial 16S rRNA sequencing will be performed	Month 12
Primary	Microbiome composition - Metagenomics	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.	Baseline
Primary	Microbiome composition - Metagenomics	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.	Month 1
Primary	Microbiome composition - Metagenomics	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.	Month 6
Primary	Microbiome composition - Metagenomics	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.	Month 12
Primary	Gut derived metabolites	Blood will be collected and serum extract metabolites will be isolated	Baseline
Primary	Gut derived metabolites	Blood will be collected and serum extract metabolites will be isolated	Month 1
Primary	Gut derived metabolites	Blood will be collected and serum extract metabolites will be isolated	Month 6
Primary	Gut derived metabolites	Blood will be collected and serum extract metabolites will be isolated	Month 12
Primary	Analysis of metabolic markers to determine metabolic function	Blood will be collected and serum assays for metabolic markers performed	Baseline
Primary	Analysis of metabolic markers to determine metabolic function	Blood will be collected and serum assays for metabolic markers performed	Month 1
Primary	Analysis of metabolic markers to determine metabolic function	Blood will be collected and serum assays for metabolic markers performed	Month 6
Primary	Analysis of metabolic markers to determine metabolic function	Blood will be collected and serum assays for metabolic markers performed	Month 12
Primary	Analysis of inflammatory markers to determine Inflammatory state	Blood will be collected and serum assays for inflammatory markers performed	Baseline
Primary	Analysis of inflammatory markers to determine Inflammatory state	Blood will be collected and serum assays for inflammatory markers performed	Month 1
Primary	Analysis of inflammatory markers to determine Inflammatory state	Blood will be collected and serum assays for inflammatory markers performed	Month 6
Primary	Analysis of inflammatory markers to determine Inflammatory state	Blood will be collected and serum assays for inflammatory markers performed	Month 12
Primary	Bowel function - International Bowel Function Basic and Extended Data Set Assessment	International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.	Baseline
Primary	Bowel function - Bristol Stool Scale	Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.	Baseline
Primary	Bowel function - International Bowel Function Basic and Extended Data Set Assessment	International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.	Month 1
Primary	Bowel function - Bristol Stool Scale	Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.	Month 1
Primary	Bowel function - International Bowel Function Basic and Extended Data Set Assessment	International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.	Month 6
Primary	Bowel function - Bristol Stool Scale	Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.	Month 6
Primary	Bowel function - International Bowel Function Basic and Extended Data Set Assessment	International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.	Month 12
Primary	Bowel function - Bristol Stool Scale	Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.	Month 12
Secondary	Diet	Participant records 24-hour dietary recalls	Baseline
Secondary	Diet	Participant records 24-hour dietary recalls	Month 1
Secondary	Diet	Participant records 24-hour dietary recalls	Month 6
Secondary	Diet	Participant records 24-hour dietary recalls	Month 12
Secondary	Physical activity - PARA-SCI	Complete PARA-SCI questionnaire to determine physical activity level	Baseline
Secondary	Physical activity - CDEs	Complete rehabilitation therapies survey (CDEs) to determine physical activity level	Baseline
Secondary	Physical activity - PARA-SCI	Complete PARA-SCI questionnaire to determine physical activity level	Month 1
Secondary	Physical activity - CDEs	Complete rehabilitation therapies survey (CDEs) to determine physical activity level	Month 1
Secondary	Physical activity - PARA-SCI	Complete PARA-SCI questionnaire to determine physical activity level	Month 6
Secondary	Physical activity - CDEs	Complete rehabilitation therapies survey (CDEs) to determine physical activity level	Month 6
Secondary	Physical activity - PARA-SCI	Complete PARA-SCI questionnaire to determine physical activity level	Month 12
Secondary	Physical activity - CDEs	Complete rehabilitation therapies survey (CDEs) to determine physical activity level	Month 12
Secondary	Medication List - Medical Record Review	Medical record review of prescribed medications being taken	Baseline
Secondary	Medication List - Self-report	Self-report of prescribed medications being taken	Baseline
Secondary	Medication List - Medical Record Review	Medical record review of prescribed medications being taken	Month 1
Secondary	Medication List - Self-report	Self-report of prescribed medications being taken	Month 1
Secondary	Medication List - Medical Record Review	Medical record review of prescribed medications being taken	Month 6
Secondary	Medication List - Self-report	Self-report of prescribed medications being taken	Month 6
Secondary	Medication List - Medical Record Review	Medical record review of prescribed medications being taken	Month 12
Secondary	Medication List - Self-report	Self-report of prescribed medications being taken	Month 12
Secondary	Supplement usage - Medical Record Review	Medical record review of supplements being taken	Baseline
Secondary	Supplement usage - self-report	Self-report of supplements being taken	Baseline
Secondary	Supplement usage - Medical Record Review	Medical record review of supplements being taken	Month 1
Secondary	Supplement usage - self-report	Self-report of supplements being taken	Month 1
Secondary	Supplement usage - Medical Record Review	Medical record review of supplements being taken	Month 6
Secondary	Supplement usage - self-report	Self-report of supplements being taken	Month 6
Secondary	Supplement usage - Medical Record Review	Medical record review of supplements being taken	Month 12
Secondary	Supplement usage - self-report	Self-report of supplements being taken	Month 12
Secondary	Depression	Complete PHQ9 questionnaires to determine depression level	Baseline
Secondary	Depression	Complete PHQ9 questionnaires to determine depression level	Month 1
Secondary	Depression	Complete PHQ9 questionnaires to determine depression level	Month 6
Secondary	Depression	Complete PHQ9 questionnaires to determine depression level	Month 12
Secondary	Anxiety	Complete GAD7 questionnaire to determine anxiety level	Baseline
Secondary	Anxiety	Complete GAD7 questionnaire to determine anxiety level	Month 1
Secondary	Anxiety	Complete GAD7 questionnaire to determine anxiety level	Month 6
Secondary	Anxiety	Complete GAD7 questionnaire to determine anxiety level	Month 12
Secondary	Comorbidities	Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction	Baseline
Secondary	Comorbidities	Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction	Month 1
Secondary	Comorbidities	Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction	Month 6
Secondary	Comorbidities	Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction	Month 12