HealthyEarly Phase 1NCT06033222
A Study of Perturbation of Human Small Intestinal Colonic Permeability
A Early Phase 1 study testing Ricinoleic Acid 750 mg, Ricinoleic Acid 1500 mg and Ricinoleic Acid 3000 mg in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of castor oil versus placebo on intestinal permeability in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ricinoleic Acid 750 mg, Ricinoleic Acid 1500 mg and Ricinoleic Acid 3000 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 31 Jul 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, non-obese, non-pregnant volunteers.
- 1:1 Male/Female Ratio.
- BMI < 30 kg/m^2.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Ricinoleic Acid 750 mg, Ricinoleic Acid 1500 mg, Ricinoleic Acid 3000 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ricinoleic Acid 750 mgDietary supplement
750 mg administered orally
Ricinoleic Acid 1500 mgDietary supplement
1500 mg administered orally
Ricinoleic Acid 3000 mgDietary supplement
3000 mg administered orally
PlaceboDrug
Contains no active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary excretion of 13^C-mannitol
Percent urinary excretion of 13^C-mannitol
Measured: 0-2 hours, 2-8 hours and 8-24 hours
Secondary outcomes (1)
Change in urinary excretion of lactulose
Percent urinary excretion of lactulose
Measured: 0-2 hours, 2-8 hours and 8-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start8 Jan 2024
- Primary completion23 May 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized, placebo-control study of effect of castor oil on intestinal and colonic permeability
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Camilleri, MD, Mayo Clinic
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033222
- Sponsor's protocol ID
- 23-003520
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Approach to Perturbation of Human Small Intestinal and Colonic Permeability in Healthy Participants
- ClinicalTrials.gov ID
- NCT06033222
- Acronym / sponsor ID
- 23-003520
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Prospective randomized, placebo-control study of effect of castor oil on intestinal and colonic permeability
| Arm | Type | Receives |
|---|---|---|
| 750 mg castor oil treatment group | Experimental | Dietary Supplement: Ricinoleic Acid 750 mgSubjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days |
| 1500 mg castor oil treatment group | Experimental | Dietary Supplement: Ricinoleic Acid 1500 mgSubjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days |
| 3000 mg castor oil treatment group | Experimental | Dietary Supplement: Ricinoleic Acid 3000 mgSubjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days |
| Placebo group | Placebo comparator | Drug: PlaceboSubjects will take placebo daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy, non-obese, non-pregnant volunteers.
- 1:1 Male/Female Ratio.
- BMI < 30 kg/m^2.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ricinoleic Acid 750 mg750 mg administered orally | Dietary supplement | 750 mg castor oil treatment group |
| Ricinoleic Acid 1500 mg1500 mg administered orally | Dietary supplement | 1500 mg castor oil treatment group |
| Ricinoleic Acid 3000 mg3000 mg administered orally | Dietary supplement | 3000 mg castor oil treatment group |
| PlaceboContains no active ingredient. | Drug | Placebo group |
Primary outcome
Change in urinary excretion of 13^C-mannitol
Time frame: 0-2 hours, 2-8 hours and 8-24 hours
Percent urinary excretion of 13^C-mannitol
1 secondary outcome
Change in urinary excretion of lactulose
Time frame: 0-2 hours, 2-8 hours and 8-24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Camilleri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ricinoleic Acid 750 mg, Ricinoleic Acid 1500 mg and Ricinoleic Acid 3000 mg in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urinary excretion of 13^C-mannitol (time frame: 0-2 hours, 2-8 hours and 8-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.