Gut Microbiomes in HD

ConditionHuntington Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Central Florida

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years or older

Provide informed consent

Able to read and speak English

Agree to comply with study procedures

Disqualifiers

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.

System antibiotics, antifungals, antivirals, or anti-parasitics (intravenous, intramuscular, or oral)

Trial population

This study aims to recruit approximately 36 adult participants: 12 for the control group (who do not have the HD gene mutation), 12 for experimental group 1 (underweight HD patients), and 12 for experimental group 2 (overweight HD patients). There may be some variation in participant number depending on recruitment success. Experimental group 1 will target underweight HD patients and experimental group 2 will target normal to overweight HD patients.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

36 Participants

are grouped into 3 trial groups

Group A: Control

Group B: Experimental Group 1

Group C: Experimental Group 2

Trial outcomes

Primary outcomes

To quantify relative abundance of entire gut microbiomes in people using Metagenomic analysis

Metagenomic analysis via 16S ribosomal RNA (rRNA) gene sequencing will be performed on HD and control stool samples to identify HD-associated changes in microbe abundance at the genus level.

Time frame

5 years

Secondary outcomes

To quantify relative abundance of candidate microbes in HD and control gut using quantitative PCR.

Using primers specific for microbes responsible for microbiota-derived metabolites that are altered in HD plasma as well as candidate microbes identified through aim 1, quantitative PCR (qPCR) will be used for quantifying relative abundance within the gut at the species level.

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Central Florida

Lead sponsor

University of South Florida

Collaborator

Source ClinicalTrials.gov

Apply now