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Gut Microbiomes in HD
Investigating the Role of the Gut Microbiome in Huntington's Disease
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility 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 monthsAbout the study
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.
Sponsor: University of Central Florida · Participants: 36 · Started: 2025-06
Contact the study team
- Amoy Fraser, PhD, CCRP, PMP · Phone: 4072668742
Official record on ClinicalTrials.gov — NCT06448546
Locations in the U.S.
| Florida | University of Central Florida, Orlando |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.