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Traumatic Brain Injury and the Gut Microbiome

NCT04949607 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-07-20

No results posted yet for this study

Summary

The purpose of the study is to determine whether administration of a prebiotic, inulin, can improve the symptom complex associated with traumatic brain injury and whether inulin administration can alter the bacteria that live in the gut.

Conditions

  • Brain Injury, Chronic
  • Brain Injuries, Traumatic

Interventions

DIETARY_SUPPLEMENT

Inulin fructooligosaccharide

Subjects will be administered inulin at a starting dose of 1g twice daily (2g/day) and ramping up an additional 2g/day until the final dose of 4g twice daily (8g/day), which will continue on until the end of month 3 (week 12). After the month 3 study visit, inulin dosing will begin to ramp down over the next week.

Sponsors & Collaborators

  • University of Texas

    collaborator OTHER

  • Centre for Neuro Skills

    lead INDUSTRY

Principal Investigators

  • Brent Masel, MD · Centre for Neuro Skills

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2022-06-08
Completion
2022-06-08

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04949607 on ClinicalTrials.gov