Study Results
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View full resultsBasic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2023-07-01
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Younger participants
Individuals aged 18-39 years.
Hyperthermia Trial
Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.
Control Trial
Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.
Older participants
Individuals aged over 65 years.
Hyperthermia Trial
Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.
Control Trial
Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.
Interventions
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Hyperthermia Trial
Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.
Control Trial
Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.
Eligibility Criteria
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Inclusion Criteria
* 18-35 years or 65+ years of age
* Free of any underlying moderate to serious medical conditions
Exclusion Criteria
* Any chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, inflammatory bowel disease, and uncontrolled hypercholestrolmia etc;
* Abnormality detected on routine screening suggestive of provocable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram.
* Current smokers, as well as individuals who regularly smoked within the past 3 years
* Subject with a body mass index ≥35 kg/m2
* Pregnant
* Use of immunosuppressant drugs within last 4 weeks prior to screening
* Use of antibiotics or antimicrobial medication in last month
* Any previous abdominal surgery
* Use of steroids in last 6 weeks
* Regular use of probiotics in last month
* Use of laxatives or anti-diarrhetic in last month
18 Years
ALL
Yes
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Craig Crandall
Professor
Principal Investigators
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Craig G Crandall, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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Texas Health Presbyterian Hospital Dallas
Dallas, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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STU-2023-0171
Identifier Type: -
Identifier Source: org_study_id
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