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RECRUITINGOBSERVATIONAL

Gut Microbiomes in HD

Investigating the Role of the Gut Microbiome in Huntington's Disease

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

* Who May Qualify: - 18 years or older - Provide willing to sign a consent form - 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 - Who Should NOT Join This Trial: - 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
* 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

Locations (1)

University of Central Florida
Orlando, Florida, United States