NCT06448546Recruiting
Gut Microbiomes in HD
Investigating the Role of the Gut Microbiome in Huntington's Disease
Source: ClinicalTrials.gov · Last updated 18 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 36 (estimated)
- First submitted
- 3 Jun 2024
- Start date
- Jun 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- University of Central Florida
- Diseases
- Huntington's disease
- NCT number
- NCT06448546
What you commit to
- Study type: Observational
- Planned participants: 36
- From Jun 2025 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Central Florida Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.