A Study of Perturbation of Human Small Intestinal Colonic Permeability

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06033222

Collaborator

(none)

Enrollment

Location

Arms

9.7

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Ricinoleic Acid 750 mg Dietary Supplement: Ricinoleic Acid 1500 mg Dietary Supplement: Ricinoleic Acid 3000 mg Drug: Placebo	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective randomized, placebo-control study of effect of castor oil on intestinal and colonic permeabilityProspective randomized, placebo-control study of effect of castor oil on intestinal and colonic permeability

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Sep 10, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Change in urinary excretion of 13^C-mannitol [0-2 hours, 2-8 hours and 8-24 hours]
Percent urinary excretion of 13^C-mannitol

Secondary Outcome Measures

Change in urinary excretion of lactulose [0-2 hours, 2-8 hours and 8-24 hours]
Percent urinary excretion of lactulose

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Minnesota	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Michael Camilleri, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Michael Camilleri, MD, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT06033222

Other Study ID Numbers:

23-003520

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of Sep 13, 2023