RECRUITING

Gut Microbiomes in HD

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Huntington DiseaseHDGut Microbiome

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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 purpose of this study is to find out if there is a connection between the naturally occurring bacteria in our bodies and the progression of Huntington disease. The investigators are trying to determine if patients who are diagnosed with adult-onset HD and who exhibit a rapid rate of disease progression have unique populations of bacteria in their gut as compared to patients with slower progression.

Official Title

Investigating the Role of the Gut Microbiome in Huntington's Disease

Quick Facts

Study Start:2025-06
Study Completion:2029-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06448546

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. * 18 years or older
  2. * Provide informed consent
  3. * Able to read and speak English
  4. * Agree to comply with study procedures
  5. * Inclusion criteria for the control group include:
  6. * CAG repeat length ≤ 26.
  7. * BMI 18.5-24.9
  8. * Inclusion criteria for experimental group 1 include:
  9. * BMI \< 18.5 (underweight) or significant, involuntary weight loss within the past 12 months.
  10. * CAG repeat length 40 - 59.
  11. * Documentation of the Clinical Diagnosis of HD with a high level of certainty (\>99% confidence) using the validated Unified Huntington's Disease Rating Scale (UHDRS).
  12. * Stage I-III on the Functional Assessment component of the UHDRS
  13. * Inclusion criteria for experimental group 2 include:
  14. * BMI \> 25.0 (overweight - obesity) or BMI ≤ 25.0 with significant, unexplained weight gain within the past 12 months
  15. * CAG repeat length 40 - 59.
  16. * Documentation of the Clinical Diagnosis of HD with a high level of certainty (\>99% confidence) using the validated UHDRS.
  17. * Stage I-III on the Functional Assessment component of the UHDRS
  18. *
  1. * CAG repeat length ≥ 60 to exclude participants with juvenile onset HD.
  2. * CAG repeat length 36 - 39 to exclude participants with reduced penetrance. As this is a pilot study, we are primarily interested in participants with typical HD characteristics.
  3. * UHDRS Functional Capacity stage ≥ 4 to exclude late-stage HD patients who may be institutionalized and receive nutrition through a feeding tube.
  4. * Use of any of the following drugs within the last 6 months:
  5. * System antibiotics, antifungals, antivirals, or anti-parasitics (intravenous, intramuscular, or oral)
  6. * Corticosteroids (intravenous, intramuscular, oral, nasal, or inhaled)
  7. * Cytokines
  8. * Methotrexate, immunosuppressive cytotoxic agents, or chemotherapy
  9. * Commercial probiotics ≥ 100 million CFU (fermented foods, yogurts, and other homeopathic probiotics and prebiotics do not apply)
  10. * Use of topical antibiotics or topical steroids within the last 7 days
  11. * History of active, uncontrolled gastrointestinal disorders or diseases, including:
  12. * Inflammatory bowel disease
  13. * Ulcerative colitis
  14. * Crohn's disease
  15. * Irritable bowel syndrome
  16. * Infectious gastroenteritis, colitis, or gastritis
  17. * Clostridium difficile or Helicobacter pylori infection
  18. * Persistent or chronic constipation or diarrhea
  19. * Acute illness with or without fever at time of sample collection
  20. * Positive for HIV, hepatitis B, or hepatitis C
  21. * Confirmed or suspected immunodeficient condition/state
  22. * Major surgery of the GI tract, excluding cholecystectomy and appendectomy
  23. * Unstable dietary history within the past month, such as elimination or significant increase of a major food group in the diet
  24. * Recent history of chronic, excessive alcohol consumption
  25. * Travel outside of the United States within the last 3 months

Contacts and Locations

Study Contact

Amoy Fraser, PhD, CCRP, PMP
CONTACT
4072668742
amoy.fraser@ucf.edu

Principal Investigator

Amber Southwell, PhD
PRINCIPAL_INVESTIGATOR
University of Central Florida

Study Locations (Sites)

University of Central Florida
Orlando, Florida, 32816
United States

Collaborators and Investigators

Sponsor: University of Central Florida

  • Amber Southwell, PhD, PRINCIPAL_INVESTIGATOR, University of Central Florida

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 Date2025-06
Study Completion Date2029-06

Study Record Updates

Study Start Date2025-06
Study Completion Date2029-06

Terms related to this study

Keywords Provided by Researchers

  • Huntington Disease
  • HD
  • Gut Microbiome

Additional Relevant MeSH Terms

  • Huntington Disease