A Study of Perturbation of Human Small Intestinal Colonic Permeability

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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Ricinoleic Acid 750 mg; Dietary supplement: Ricinoleic Acid 1500 mg; Dietary supplement: Ricinoleic Acid 3000 mg; Drug: Placebo

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 adults.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Minnesota
      • Contact: Deb Eckert, RN; Phone Number: 507-538-5860; Email: eckert.deborah@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 750 mg castor oil treatment group; Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days	Dietary supplement: Ricinoleic Acid 750 mg; 750 mg administered orally
Experimental: 1500 mg castor oil treatment group; Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days	Dietary supplement: Ricinoleic Acid 1500 mg; 1500 mg administered orally
Experimental: 3000 mg castor oil treatment group; Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days	Dietary supplement: Ricinoleic Acid 3000 mg; 3000 mg administered orally
Placebo Comparator: Placebo group; Subjects will take placebo daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days	Drug: Placebo; Contains no active ingredient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in urinary excretion of lactulose	Percent urinary excretion of lactulose	0-2 hours, 2-8 hours and 8-24 hours

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Michael Camilleri, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Actual): January 23, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 23-003520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes