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Gut Microbiomes in Huntington Disease Study

This study is looking into the connection between the bacteria living in our guts (gut microbiomes) and how Huntington disease (HD) progresses. Researchers want to see if people with adult-onset HD who experience a rapid worsening of their disease have different gut bacteria compared to those whose disease progresses more slowly. They will be analyzing the types and amounts of all the bacteria in the gut. The study aims to understand this connection over a 5-year period. You might be able to join if you are 18 or older, can read and speak English, and agree to follow the study's procedures. There are specific criteria for control groups (those without HD) and experimental groups (those with HD) based on your BMI (Body Mass Index) and a genetic marker called CAG repeat length.

Study design
This is an observational study, meaning researchers will be watching and collecting information without giving any specific treatments. It plans to include 36 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the gut microbiomes at 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06448546

Gut Microbiomes in HD

Recruiting
Not specifiedAges 18+Observational
University of Central Florida
~36 participants
Updated 2025-06-18 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To quantify relative abundance of entire gut microbiomes in people using Metagenomic analysis
Measured over 5 years

Conditions

Huntington Disease

Explore related trials

Huntington's DiseaseCAG repeat length

NCT06448546

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Central Florida

    Orlando, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Amoy Fraser, PhD, CCRP, PMP
[email protected]
4072668742
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

18 years or older
Provide informed consent
Able to read and speak English
Agree to comply with study procedures
CAG repeat length ≤ 26.
BMI 18.5-24.9
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
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

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

What this trial measures

  • To quantify relative abundance of entire gut microbiomes in people using Metagenomic analysis5 years

    Metagenomic analysis via 16S ribosomal RNA (rRNA) gene sequencing will be performed on HD and control stool samples to identify HD-associated changes in microbe abundance at the genus level.