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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06033222

Enrollment

Registered

2023-09-13

Start date

2024-01-08

Completion date

2024-07-31

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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 adults.

Interventions

DIETARY_SUPPLEMENTRicinoleic Acid 750 mg

750 mg administered orally

DIETARY_SUPPLEMENTRicinoleic Acid 1500 mg

1500 mg administered orally

DIETARY_SUPPLEMENTRicinoleic Acid 3000 mg

3000 mg administered orally

DRUGPlacebo

Contains no active ingredient.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026