Recruiting

Observational Study

Sponsor:

University of Central Florida

Code:

NCT06448546

Conditions

Huntington Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Huntington Disease

Study ID

NCT06448546

Start date

Jun, 2025

Status verified date

Jun, 2025

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

  • Inclusion Criteria:

  • 18 years or older
  • Provide informed consent
  • Able to read and speak English
  • Agree to comply with study procedures
  • Inclusion criteria for the control group include:

  • CAG repeat length ≤ 26.
  • BMI 18.5-24.9
  • Inclusion criteria for experimental group 1 include:

  • BMI < 18.5 (underweight) or significant, involuntary weight loss within the past 12 months.
  • CAG repeat length 40 - 59.
  • 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).
  • Stage I-III on the Functional Assessment component of the UHDRS
  • Inclusion criteria for experimental group 2 include:

  • BMI > 25.0 (overweight - obesity) or BMI ≤ 25.0 with significant, unexplained weight gain within the past 12 months
  • CAG repeat length 40 - 59.
  • Documentation of the Clinical Diagnosis of HD with a high level of certainty (>99% confidence) using the validated UHDRS.
  • Stage I-III on the Functional Assessment component of the UHDRS
  • Exclusion Criteria:

  • CAG repeat length ≥ 60 to exclude participants with juvenile onset HD.
  • 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.
  • UHDRS Functional Capacity stage ≥ 4 to exclude late-stage HD patients who may be institutionalized and receive nutrition through a feeding tube.
  • Use of any of the following drugs within the last 6 months:

  • System antibiotics, antifungals, antivirals, or anti-parasitics (intravenous, intramuscular, or oral)
  • Corticosteroids (intravenous, intramuscular, oral, nasal, or inhaled)
  • Cytokines
  • Methotrexate, immunosuppressive cytotoxic agents, or chemotherapy
  • Commercial probiotics ≥ 100 million CFU (fermented foods, yogurts, and other homeopathic probiotics and prebiotics do not apply)
  • Use of topical antibiotics or topical steroids within the last 7 days
  • History of active, uncontrolled gastrointestinal disorders or diseases, including:

  • Inflammatory bowel disease
  • Ulcerative colitis
  • Crohn's disease
  • Irritable bowel syndrome
  • Infectious gastroenteritis, colitis, or gastritis
  • Clostridium difficile or Helicobacter pylori infection
  • Persistent or 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/state
  • Major surgery of the GI tract, excluding cholecystectomy and appendectomy
  • Unstable dietary history within the past month, such as elimination or significant increase of a major food group in the diet
  • Recent history of chronic, excessive alcohol consumption
  • Travel outside of the United States within the last 3 months

Study Design

Enrollment

36 participants

Anticipated

Interventions and Outcome Measures

Arms

Control

Patients who are not diagnosed with HD

Experimental Group 1

Underweight HD patients

Experimental Group 2

Overweight HD patients

Primary outcome measure

  • To quantify relative abundance of entire gut microbiomes in people using Metagenomic analysis [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Amoy Fraser, PhD, CCRP, PMP

4072668742amoy.fraser@ucf.edu

Locations

University of Central Florida

Recruiting

Orlando, Florida, United States, 32816

Contacts

Amoy Fraser, PhD, CCRP, PMP

4072668742amoy.fraser@ucf.edu

Erica Martin, BS

4072668742erica.martin@ucf.edu

More Information

Sponsor

University of Central Florida

Last update posted

Jun 18, 2025

Last verified

Jun, 2025

Keywords

  • Huntington Disease
  • HD
  • Gut Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Central Florida on 2025-06-18.