Perturbation of Human Small Intestinal and Colonic Permeability on Healthy Participants
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-003520
NCT ID: NCT06033222
About this study
The purpose of this study is to conduct a study of the effects of orally administered Castor oil on small bowel and colonic permeability measured in healthy female and male adults.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Healthy, non-obese, non-pregnant volunteers.
- 1:1 Male/Female Ratio.
- BMI < 30 kg/m^2.
Exclusion Criteria:
- 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.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 3/4/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available