Gut Microbiomes in HD

Launched by UNIVERSITY OF CENTRAL FLORIDA · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the relationship between gut bacteria and Huntington disease (HD). Researchers want to find out if there are specific types of bacteria in the digestive systems of people with HD that progress quickly compared to those whose condition progresses more slowly. Understanding this connection could help improve treatment options in the future.

To participate in the study, you need to be at least 18 years old and able to read and speak English. You must also have a confirmed diagnosis of adult-onset HD with specific genetic markers and meet certain health criteria, such as having a normal body weight or being underweight or overweight. Participants will need to provide consent and follow the study procedures. It's important to note that the trial is not yet recruiting, so if you are interested, keep an eye out for updates!

Gender

ALL

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 months