A Study of Perturbation of Human Small Intestinal Colonic Permeability

Healthy Clinical Trial

Official title:

Developing an Approach to Perturbation of Human Small Intestinal and Colonic Permeability in Healthy Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033222
• Other study ID #: 23-003520
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 8, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of castor oil versus placebo on intestinal permeability in healthy individuals.

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 adults.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 31, 2024
• Est. primary completion date: May 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Ricinoleic Acid 750 mg
750 mg administered orally
• Ricinoleic Acid 1500 mg
1500 mg administered orally
• Ricinoleic Acid 3000 mg
3000 mg administered orally

Drug:
• Placebo
Contains no active ingredient.

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urinary excretion of 13^C-mannitol	Percent urinary excretion of 13^C-mannitol	0-2 hours, 2-8 hours and 8-24 hours
Secondary	Change in urinary excretion of lactulose	Percent urinary excretion of lactulose	0-2 hours, 2-8 hours and 8-24 hours