N/A
N=22
Aging and Gastrointestinal Barrier Function
Aging · Hyperthermia
Bottom Line
View on ClinicalTrials.gov: NCT05816551 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Log Lactulose/Rhamnose Following Control Trial — 0.97; 0.79 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hyperthermia Trial (Other); Control Trial (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Log Lactulose/Rhamnose Following Control Trial |
0.97; 0.79 | — |
| PRIMARY Log Lactulose/Rhamnose Following Hyperthermia Trial |
1.22; 1.21 | — |
| PRIMARY Log Sucrose Following Control Trial |
2.68; 1.74 | — |
| PRIMARY Log Sucrose Following Hyperthermia Trial |
2.83; 3.44 | — |
| SECONDARY Change in Core Temperature During Hyperthermia Trial |
2.01; 1.95 | — |
Summary
The purpose of this study is to assess the gastrointestinal responses of the elderly and younger populations during hyperthermia.
Eligibility Criteria
Inclusion Criteria
- Healthy male and female individuals
- 18-35 years or 65+ years of age
- Free of any underlying moderate to serious medical conditions
Exclusion Criteria
- Known heart disease
- 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
Data sourced from ClinicalTrials.gov (NCT05816551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.