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Gut Microbiomes in HD

University of Central Florida · with University of South Florida · NCT06448546

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
36
US sites recruiting
1
Study start
June 2025
Record last updated
June 18, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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: Huntington Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria
  • 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

Recruiting US locations

  • University of Central Florida

    Orlando, FL 32816

    Site contact: Amoy Fraser, PhD, CCRP, PMP · 4072668742 · amoy.fraser@ucf.edu

Study contacts (from the official record)

  • Amoy Fraser, PhD, CCRP, PMP · 4072668742 · amoy.fraser@ucf.edu
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Gut Microbiomes in HD (NCT06448546) | Bored Studies