NCT06448546 · University of Central Florida
Gut Microbiomes in HD
What this 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 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)
- 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
- Orlando, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2025 · Source of record for eligibility and locations