Gut bacteria in Huntington disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will compare the gut microbiome of adults with clinically confirmed adult-onset Huntington disease across groups defined by body mass index and recent involuntary weight change, and with a control group with normal CAG repeat length. Participants will provide medical history, UHDRS-based clinical staging, CAG repeat information, and stool samples for microbiome sequencing, along with metabolic and weight measurements. The goal is to identify whether distinct gut bacterial populations correlate with faster versus slower clinical progression and with obesity or pathological weight loss. Recruitment and visits occur at the University of Central Florida in Orlando.

Why it matters

Who can join: the full rules

* 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

Where it's running

• University of Central Florida
  Orlando, Florida, United States Recruiting

Study contacts

• Principal investigator: Amber Southwell, PhD — University of Central Florida
• Study coordinator: Amoy Fraser, PhD, CCRP, PMP
• Email: amoy.fraser@ucf.edu
• Phone: 4072668742

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.