Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06448546

Gut Microbiomes in HD

Led by University of Central Florida · Updated on 2025-06-18

36

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

U

University of Central Florida

Lead Sponsor

U

University of South Florida

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Gut Microbiomes in HD

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Provide informed consent
  • Able to read and speak English
  • Agree to comply with study procedures
  • For control group: CAG repeat length 26 or less and BMI between 18.5 and 24.9
  • For experimental group 1: BMI less than 18.5 or significant involuntary weight loss within the past 12 months, CAG repeat length 40 to 59, clinical diagnosis of HD with over 99% confidence using UHDRS, and stage I-III on the Functional Assessment component of UHDRS
  • For experimental group 2: BMI greater than 25.0 or BMI 25.0 or less with significant unexplained weight gain within the past 12 months, CAG repeat length 40 to 59, clinical diagnosis of HD with over 99% confidence using UHDRS, and stage I-III on the Functional Assessment component of UHDRS
Not Eligible

You will not qualify if you...

  • CAG repeat length 60 or more to exclude juvenile onset HD
  • CAG repeat length 36 to 39 to exclude reduced penetrance participants
  • UHDRS Functional Capacity stage 4 or higher to exclude late-stage HD patients
  • Use of systemic antibiotics, antifungals, antivirals, or anti-parasitics within the last 6 months
  • Use of corticosteroids within the last 6 months
  • Use of cytokines, methotrexate, immunosuppressive cytotoxic agents, or chemotherapy within the last 6 months
  • Use of commercial probiotics with 100 million CFU or more within the last 6 months
  • Use of topical antibiotics or topical steroids within the last 7 days
  • History of active, uncontrolled gastrointestinal disorders including inflammatory bowel disease, ulcerative colitis, Crohn's disease, irritable bowel syndrome, infectious gastroenteritis, colitis, gastritis, Clostridium difficile or Helicobacter pylori infection, or persistent chronic constipation or diarrhea
  • Acute illness with or without fever at time of sample collection
  • Positive for HIV, hepatitis B, or hepatitis C
  • Confirmed or suspected immunodeficient condition or state
  • Major gastrointestinal surgery excluding cholecystectomy and appendectomy
  • Unstable dietary history within the past month
  • Recent history of chronic, excessive alcohol consumption
  • Travel outside the United States within the last 3 months

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Central Florida

Orlando, Florida, United States, 32816

Actively Recruiting

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Research Team

A

Amoy Fraser, PhD, CCRP, PMP

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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