A Study of Perturbation of Human Small Intestinal Colonic Permeability

NCT06033222 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 23-003520
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in urinary excretion of lactulose

  0-2 hours, 2-8 hours and 8-24 hours

Study Arms (4)

750 mg castor oil treatment group

EXPERIMENTAL

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

1500 mg castor oil treatment group

EXPERIMENTAL

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

3000 mg castor oil treatment group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

Subjects will take placebo daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days

Drug: Placebo

Interventions

Ricinoleic Acid 750 mg DIETARY_SUPPLEMENT

750 mg administered orally

750 mg castor oil treatment group

Ricinoleic Acid 1500 mg DIETARY_SUPPLEMENT

1500 mg administered orally

1500 mg castor oil treatment group

Ricinoleic Acid 3000 mg DIETARY_SUPPLEMENT

3000 mg administered orally

3000 mg castor oil treatment group

Placebo DRUG

Contains no active ingredient.

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, non-obese, non-pregnant volunteers.
• :1 Male/Female Ratio.
• BMI \< 30 kg/m\^2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

ricinoleic acid

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: January 8, 2024
• Primary Completion: May 23, 2024
• Study Completion: July 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)