Status:
COMPLETED
A Study of Perturbation of Human Small Intestinal Colonic Permeability
Lead Sponsor:
Mayo Clinic
Conditions:
Healthy
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to evaluate the effect of castor oil versus placebo on intestinal permeability in healthy individuals.
Detailed Description
Randomized, parallel-group, placebo-controlled, blinded, dose-response study using Castor oil and see the effects it has on small bowel and colonic permeability measured in healthy female and male adu...
Eligibility Criteria
Inclusion
- Healthy, non-obese, non-pregnant volunteers.
- 1:1 Male/Female Ratio.
- BMI \< 30 kg/m\^2.
Exclusion
- Diabetes.
- Uncontrolled hypertension (with BP measured \> 140/90mmHg in the CRTU)
- BMI ≥ 30 kg/m\^2.
- Chronic NSAID use (\> 1 day/week).
- Use of oral antibiotics for 2 weeks prior to and during the entire 5 day study period.
- Known intolerance of castor oil.
- Diagnosis of gastrointestinal diseases that are associated with abnormal intestinal or colonic permeability such as inflammatory bowel diseases, irritable bowel syndrome and celiac disease.
- Prior intestinal or colonic resection.
- Participation in highly vigorous exercise such as running \> 5 miles per day in week prior to the permeability test.
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06033222
Start Date
January 8 2024
End Date
July 31 2024
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905