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Castor Oil for Gut Health in Healthy Subjects

Q: Would I be eligible to participate in this research initiative?

In order to be admitted into this experiment, potential participants must possess healthy bodies and fall between 18-70 years of age. Currently, 24 candidates are being sought out for the trial.

Q: Does the criteria for this study encompass those who are aged 50 or above?

The specified age range for participants in this trial is 18 to 70. Separately, the database has 63 trials catered towards minors and another 405 focused on senior citizens aged 65 or older.

Q: Has this experiment begun enrolling participants?

This clinical trial is no longer open to enrollment, as the online listing on clinicaltrials.gov was last updated September 5th 2023. However, numerous other studies are actively recruiting patients at this time with 834 trials listed in total.

Phase < 1

Recruiting

Led By Michael Camilleri, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1:1 Male/Female Ratio

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial studies the effect of castor oil on gut health in healthy people, comparing it to a fake treatment.

Who is the study for?

This trial is for healthy, non-obese individuals with a BMI under 30 who are not pregnant. An equal number of men and women can join. People with diabetes, high blood pressure, recent antibiotic use, gastrointestinal diseases like IBS or celiac disease, frequent NSAID use, intolerance to castor oil, prior gut surgery or intense exercise habits cannot participate.Check my eligibility

What is being tested?

The study is testing the effects of different doses of Ricinoleic Acid (750 mg, 1500 mg, and 3000 mg) compared to a placebo on how well the small intestine and colon control what passes through them in healthy people.See study design

What are the potential side effects?

While specific side effects aren't listed here for Ricinoleic Acid or the placebo used in this trial; generally speaking, participants might experience digestive discomfort such as cramps or diarrhea due to the nature of substances being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I understand the study aims for equal numbers of male and female participants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-2 hours, 2-8 hours and 8-24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-2 hours, 2-8 hours and 8-24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-2 hours, 2-8 hours and 8-24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in urinary excretion of 13^C-mannitol

Secondary outcome measures

Change in urinary excretion of lactulose

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 750 mg castor oil treatment groupExperimental Treatment1 Intervention

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

Group II: 3000 mg castor oil treatment groupExperimental Treatment1 Intervention

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

Group III: 1500 mg castor oil treatment groupExperimental Treatment1 Intervention

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

Group IV: Placebo groupPlacebo Group1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,464 Total Patients Enrolled

Michael Camilleri, MDPrincipal InvestigatorMayo Clinic

38 Previous Clinical Trials

3,248 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I be eligible to participate in this research initiative?

"In order to be admitted into this experiment, potential participants must possess healthy bodies and fall between 18-70 years of age. Currently, 24 candidates are being sought out for the trial."

Answered by AI

Does the criteria for this study encompass those who are aged 50 or above?

"The specified age range for participants in this trial is 18 to 70. Separately, the database has 63 trials catered towards minors and another 405 focused on senior citizens aged 65 or older."

Answered by AI

Has this experiment begun enrolling participants?

"This clinical trial is no longer open to enrollment, as the online listing on clinicaltrials.gov was last updated September 5th 2023. However, numerous other studies are actively recruiting patients at this time with 834 trials listed in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Perturbation of Human Small Intestinal Colonic Permeability

Michael Camilleri, MD 2024. "A Study of Perturbation of Human Small Intestinal Colonic Permeability". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06033222.