RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-15
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05670288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18-85 years of age
  2. 2. diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2)
  3. 3. classification of A, B, C (motor complete, incomplete).
  1. 1. Women who are pregnant prior to consent
  2. 2. neurological impairment other than SCI
  3. 3. self-reported history of Crohn's disease or diverticulitis
  4. 4. irritable bowel syndrome
  5. 5. gastric blockage/obstruction or swallowing disorder
  6. 6. prior GI surgery
  7. 7. intrathecal pump
  8. 8. concurrent usage of functional electrical stimulation for bowel management (e.g., constipation).
  9. 9. able to ambulate

Contacts and Locations

Study Contact

Jereme Wilroy, PhD
CONTACT
(205) 934-0355
jdwilroy@uab.edu

Principal Investigator

Jereme Wilroy, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

The University of Alabama at Birmingahm
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Jereme Wilroy, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-15
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2023-10-15
Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

  • SCI
  • Inflammation
  • Bowel Function
  • Blood Sugar
  • Lipid Profiles

Additional Relevant MeSH Terms

  • Spinal Cord Injuries
  • Gut Microbiome