Abdominal PainPhase 1PMONCT03295747
Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain
A Phase 1 study testing Peppermint oil in people with Abdominal Pain, run by Robert Shulman, M.D. at 1 site in United States.
Trial summary
Aim 1 - Determine the pharmacokinetics of PMO (menthol) of three different doses in children with functional abdominal pain (FAP) (n=30). Aim 2 - Determine pharmacodynamic effect of three different doses of PMO on gut microbiome composition and contractile activity/gut transit rate. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Peppermint oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2017to 28 Mar 2019
- Phase
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 7-12 years old
- They will be able to complete the protocol
- A child will be recruited if the medical evaluation reveals no organic reason for the abdominal pain
Who cannot join
- Children who have had past bowel surgery;
- A child with documented GI disorders (e.g., Crohn's disease);
- A child with a serious chronic medical condition (e.g., diabetes);
- A child with a weight and/or height < 2 SD for age;
- Children with chronic conditions with GI symptoms (e.g., cystic fibrosis);
- Children with autism spectrum disorder, significant developmental delay, psychosis, depression, or a history of bipolar disorder;
- Children who have been treated with antibiotics/probiotics within 2 mo. (because of effects on microbiome analysis).
- Children who speak only Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Aim 1 - Determine the pharmacokinetics of PMO (menthol) of three different doses in children with functional abdominal pain (FAP) (n=30).
Aim 2 - Determine pharmacodynamic effect of three different doses of PMO on gut microbiome composition and contractile activity/gut transit rate.
Read the detailed description
Children with functional abdominal pain (FAP) ages 7-12 years (n=30) will be recruited.
The study participants will be admitted to the Children's Nutrition Research Center. A medical history and a general physical examination performed by the investigator or the research nurse. The height, weight, and vital signs (pulse rate, respiratory rate, and seated blood pressure) will be obtained. After application of a topical anesthetic to the site chosen for study-related blood sampling, a cannula will be inserted e to obtain repeated blood samples.
At approximately 0900, subjects will receive one of three doses of PMO as a single oral dose. Immediately prior to administration of the PMO, a blood sample will be obtained to measure total menthol concentration and leukocytes for isolation of DNA for CYP2A6 and UGT2B7 genotyping.
After PMO administration, repeated blood samples will be obtained over 24 hours.
At 2 hours after PMO administration, participants will be given a standardized meal and will eat ad libitum thereafter.
After completion of the final (24 hours) blood samples, vital signs will be reassessed and the venous cannula removed. Parents will receive a follow-up call from the research coordinator to access/evaluate if any adverse effects from dose or blood sampling received at the overnight study visit.
Prior to and after administration of peppermint oil (PMO) for 1 week at the dose defined above, children will undergo measurement of gut microbiome composition and GI motility and transit time. At the time of the stool collection, the child will also keep a 3 day diet history.
- Conditions
- Abdominal Pain
- Being tested
- Peppermint oil
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peppermint oilDrug
Also called Enteric coated peppermint oil capsules
Three doses of peppermint oil will be investigated: 180, 360, 540 mg; i.e. three arms.
| Study group | Role | What they receive |
|---|---|---|
| 180 mg | Experimental | 180 mg of peppermint oil Receives: Drug: Peppermint oil |
| 360 mg | Experimental | 360 mg of peppermint oil Receives: Drug: Peppermint oil |
| 540 mg | Experimental | 540 mg of peppermint oil Receives: Drug: Peppermint oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Area under the curve
Measured: 24 hours
Secondary outcomes (3)
Contractility
Number and amplitude of gut contractions as measured by SmartPill
Measured: Prior to and during peppermint oil treatment
Gut Microbiome Composition
Microbiome is defined for this study as a statistically significant change from baseline after treatment with PMO, correcting for multiple testing (q value). Such changes may occur with respect to gut microbiome diversity and/or composition (e.g., phylum, family, genera). We anticipate there will be an increased bacterial diversity, as well as increases in the abundance of organisms associated with a healthy microbiome, in response to PMO administration.
Measured: Prior to and during peppermint oil treatment
Motility
Gut transit time as measured by SmartPill
Measured: Prior to and during peppermint oil treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start15 Oct 2017
- Primary completion28 Mar 2019
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized to one of three prospective arms as reflected by three treatment doses for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Shulman, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Shulman, M.D., Baylor College of Medicine
- Investigators
- Shulman J. Shulman, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295747
- Sponsor's protocol ID
- R21AT009101-01
- Acronym
- PMO
- Status last verified
- Apr 2022
- First submitted
- 2 Dec 2016
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shulman RJ, Chumpitazi BP, Abdel-Rahman SM, Garg U, Musaad S, Kearns GL. Randomised trial: Peppermint oil (menthol) pharmacokinetics in children and effects on gut motility in children with functional abdominal pain. Br J Clin Pharmacol. 2022 Mar;88(3):1321-1333. doi: 10.1111/bcp.15076. Epub 2021 Oct 19.
PubMed 34528282Thapa S, Luna RA, Chumpitazi BP, Oezguen N, Abdel-Rahman SM, Garg U, Musaad S, Versalovic J, Kearns GL, Shulman RJ. Peppermint oil effects on the gut microbiome in children with functional abdominal pain. Clin Transl Sci. 2022 Apr;15(4):1036-1049. doi: 10.1111/cts.13224. Epub 2022 Jan 20.
PubMed 35048535
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain
- ClinicalTrials.gov ID
- NCT03295747
- Acronym / sponsor ID
- PMO / R21AT009101-01
- Conditions
- Abdominal Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Robert Shulman, M.D.University, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 28 Sep 2017 (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.
Aim 1 - Determine the pharmacokinetics of PMO (menthol) of three different doses in children with functional abdominal pain (FAP) (n=30).
Aim 2 - Determine pharmacodynamic effect of three different doses of PMO on gut microbiome composition and contractile activity/gut transit rate.
Detailed description
Children with functional abdominal pain (FAP) ages 7-12 years (n=30) will be recruited.
The study participants will be admitted to the Children's Nutrition Research Center. A medical history and a general physical examination performed by the investigator or the research nurse. The height, weight, and vital signs (pulse rate, respiratory rate, and seated blood pressure) will be obtained. After application of a topical anesthetic to the site chosen for study-related blood sampling, a cannula will be inserted e to obtain repeated blood samples.
At approximately 0900, subjects will receive one of three doses of PMO as a single oral dose. Immediately prior to administration of the PMO, a blood sample will be obtained to measure total menthol concentration and leukocytes for isolation of DNA for CYP2A6 and UGT2B7 genotyping.
After PMO administration, repeated blood samples will be obtained over 24 hours.
At 2 hours after PMO administration, participants will be given a standardized meal and will eat ad libitum thereafter.
After completion of the final (24 hours) blood samples, vital signs will be reassessed and the venous cannula removed. Parents will receive a follow-up call from the research coordinator to access/evaluate if any adverse effects from dose or blood sampling received at the overnight study visit.
Prior to and after administration of peppermint oil (PMO) for 1 week at the dose defined above, children will undergo measurement of gut microbiome composition and GI motility and transit time. At the time of the stool collection, the child will also keep a 3 day diet history.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants randomized to one of three prospective arms as reflected by three treatment doses for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| 180 mg | Experimental | Drug: Peppermint oil180 mg of peppermint oil |
| 360 mg | Experimental | Drug: Peppermint oil360 mg of peppermint oil |
| 540 mg | Experimental | Drug: Peppermint oil540 mg of peppermint oil |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children ages 7-12 years old
- They will be able to complete the protocol
- A child will be recruited if the medical evaluation reveals no organic reason for the abdominal pain
Key exclusion criteria (8 listed)
- Children who have had past bowel surgery;
- A child with documented GI disorders (e.g., Crohn's disease);
- A child with a serious chronic medical condition (e.g., diabetes);
- A child with a weight and/or height < 2 SD for age;
- Children with chronic conditions with GI symptoms (e.g., cystic fibrosis);
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 |
|---|---|---|
| Peppermint oilAlso: Enteric coated peppermint oil capsulesThree doses of peppermint oil will be investigated: 180, 360, 540 mg; i.e. three arms. | Drug | 180 mg, 360 mg, 540 mg |
Primary outcome
Pharmacokinetics
Time frame: 24 hours
Area under the curve
3 secondary outcomes
Contractility
Time frame: Prior to and during peppermint oil treatment
Gut Microbiome Composition
Time frame: Prior to and during peppermint oil treatment
Motility
Time frame: Prior to and during peppermint oil treatment
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 6 Apr 2022.
- Results publication: PubMed 34528282Shulman RJ, Chumpitazi BP, Abdel-Rahman SM, Garg U, Musaad S, Kearns GL. Randomised trial: Peppermint oil (menthol) pharmacokinetics in children and effects on gut motility in children with functional abdominal pain. Br J Clin Pharmacol. 2022 Mar;88(3):1321-1333. doi: 10.1111/bcp.15076. Epub 2021 Oct 19.
- Results publication: PubMed 35048535Thapa S, Luna RA, Chumpitazi BP, Oezguen N, Abdel-Rahman SM, Garg U, Musaad S, Versalovic J, Kearns GL, Shulman RJ. Peppermint oil effects on the gut microbiome in children with functional abdominal pain. Clin Transl Sci. 2022 Apr;15(4):1036-1049. doi: 10.1111/cts.13224. Epub 2022 Jan 20.
- 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.
Shulman J. Shulman, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Peppermint oil in people with Abdominal Pain, run by Robert Shulman, M.D. 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 8 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 6 Apr 2022. 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. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetics (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03295747, which also lists 2 linked publications.
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 6 Apr 2022.