RECRUITING

The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms

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 aim of this study is to characterize the microbiome of patients undergoing post-acute residential neurorehabilitation compared to community controls and to determine if a dietary fiber, Inulin, can create a shift in the microbiome leading to changes in fatigue and cognition.

Official Title

The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms

Quick Facts

Study Start:2025-02-01
Study Completion:2028-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06607523

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Kate Randolph, BS
CONTACT
409-772-8126
kmrandol@utmb.edu
Christopher Danesi, MS
CONTACT
409-772-8126
cpdanesi@utmb.edu

Principal Investigator

Randall Urban, MD
PRINCIPAL_INVESTIGATOR
University of Texas
Ana Durand, MD
STUDY_DIRECTOR
Moody Neurorehabilitation Institute

Study Locations (Sites)

University of Texas Medical Branch
Galveston, Texas, 77555
United States

Collaborators and Investigators

Sponsor: The University of Texas Medical Branch, Galveston

  • Randall Urban, MD, PRINCIPAL_INVESTIGATOR, University of Texas
  • Ana Durand, MD, STUDY_DIRECTOR, Moody Neurorehabilitation Institute

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 Date2025-02-01
Study Completion Date2028-10-01

Study Record Updates

Study Start Date2025-02-01
Study Completion Date2028-10-01

Terms related to this study

Keywords Provided by Researchers

  • Brain Injury
  • Neurorehabilitation
  • Fatigue
  • Cognition

Additional Relevant MeSH Terms

  • Brain Injuries