Abdominal PainPhase 1NCT04497870
Peppermint Oil Pharmacokinetics/Dynamics
A Phase 1 study testing Peppermint oil in people with Abdominal Pain, run by Baylor College of Medicine at 1 site in United States.
Trial summary
In children 7-12 years of age with functional abdominal pain (n=42) determine: Aim 1 - To examine and characterize the threshold of the exposure (PK) vs. response (PD) relationship of PMO (menthol) Aim 2 - PD of PMO as assessed by: 1. Microbiome composition (16S RNA sequencing) 2. 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2020to 14 Sep 2023
- 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 who are able to assent to the procedures
- Able to complete the diaries which have been validated for use in this age range
- The history and medical evaluation reveal no organic reason for the abdominal pain
- The child has abdominal pain that meets the definition of FAP according to pediatric Rome IV
- Ability to understand study procedures and to comply with them for the entire length of the study
- Childrens' body weights will not vary by more than 10-15 kg (so that dose per kg is comparable within the two dosing groups)
Who cannot join
- Past bowel surgery
- Documented GI disorders (e.g., Crohn's disease)
- A serious chronic medical condition (e.g., diabetes)
- A weight and/or height < 2 SD for age
- Chronic conditions with GI symptoms (e.g., cystic fibrosis)
- Autism spectrum disorder, significant developmental delay, psychosis, depression, or a history of bipolar disorder
Show all 11Show fewer
- Antibiotic/probiotic treatment within 2 mo.
- Allergy/sensitivity to PMO or its ingredients
- Inability to swallow the PMO capsule or the SmartPill®
- Inability to speak English - testing materials are available only in this language
- Unable to discontinue laxative, prokinetic, or neuromodulator from 3 wk prior to Visit 1 through the end of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Nutrition Research Center
Houston, Texas, 77030
About this study
Official title: Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain
In children 7-12 years of age with functional abdominal pain (n=42) determine:
Aim 1 - To examine and characterize the threshold of the exposure (PK) vs. response (PD) relationship of PMO (menthol)
Aim 2 - PD of PMO as assessed by:
- Microbiome composition (16S RNA sequencing)
- Transit rate/contractile activity (using the SmartPill®) Aim 3 - Evaluate the potential association between PD response and clinical symptoms (abdominal pain and stooling pattern via validated diary), psychosocial distress (anxiety, depression, somatization), and characterize potential side effects (questionnaire)
Read the detailed description
An initial single-dose PK study will be carried out. Forty-two children (n=21 per dose) will be randomized to receive approximately 10.9 mg·kg-1·d-1 of PMO or to receive approximately 18.2 mg·kg-1·d-1 (1.67-fold the median dose).
Following the single-dose PK study, a PD study will be carried out wherein the subjects will receive their assigned dose of PMO for 7 days.
At baseline (before the PK study) and after the PK study (i.e., during the PD study), subjects will keep a pain and stooling diary, collect stool for microbiome analysis, and swallow a SmartPill to measure gut motility and transit time. At baseline only, anxiety, depression, somatization will be measured. During the PD study, any side effects will be recorded.
- 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 menthol
Administration of peppermint oil at one of two daily doses.
| Study group | Role | What they receive |
|---|---|---|
| 540 mg | Active comparator | Peppermint oil at a dose of 180 mg thrice daily orally Receives: Drug: Peppermint oil |
| 900 mg | Experimental | Peppermint oil at a dose of 180 mg five times daily orally Receives: Drug: Peppermint oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of peppermint oil
Area under the curve
Measured: 2 weeks
Gut Microbiome composition
Gut microbiome composition as determined by 16S sequencing as a consequence of the administration of peppermint oil at the two doses given.
Measured: 2 weeks
Gut transit time
Gut transit time as a consequence of the administration of peppermint oil at the two doses given.
Measured: 2 weeks
Gut contractility
Gut contractility as a consequence of the administration of peppermint oil at the two doses given.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start9 Jul 2020
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Why it stopped: This study was superseded by NCT03295747
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Shulman, M.D., Baylor College of Medicine
- Investigators
- Robert J Shulman, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497870
- Sponsor's protocol ID
- H-40351
- Status last verified
- Dec 2023
- First submitted
- 22 Jun 2020
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Dec 2023. 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
- NCT04497870
- Acronym / sponsor ID
- H-40351
- Conditions
- Abdominal Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was superseded by NCT03295747
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 4 Aug 2020 (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.
In children 7-12 years of age with functional abdominal pain (n=42) determine:
Aim 1 - To examine and characterize the threshold of the exposure (PK) vs. response (PD) relationship of PMO (menthol)
Aim 2 - PD of PMO as assessed by:
- Microbiome composition (16S RNA sequencing)
- Transit rate/contractile activity (using the SmartPill®) Aim 3 - Evaluate the potential association between PD response and clinical symptoms (abdominal pain and stooling pattern via validated diary), psychosocial distress (anxiety, depression, somatization), and characterize potential side effects (questionnaire)
Detailed description
An initial single-dose PK study will be carried out. Forty-two children (n=21 per dose) will be randomized to receive approximately 10.9 mg·kg-1·d-1 of PMO or to receive approximately 18.2 mg·kg-1·d-1 (1.67-fold the median dose).
Following the single-dose PK study, a PD study will be carried out wherein the subjects will receive their assigned dose of PMO for 7 days.
At baseline (before the PK study) and after the PK study (i.e., during the PD study), subjects will keep a pain and stooling diary, collect stool for microbiome analysis, and swallow a SmartPill to measure gut motility and transit time. At baseline only, anxiety, depression, somatization will be measured. During the PD study, any side effects will be recorded.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 540 mg | Active comparator | Drug: Peppermint oilPeppermint oil at a dose of 180 mg thrice daily orally |
| 900 mg | Experimental | Drug: Peppermint oilPeppermint oil at a dose of 180 mg five times daily orally |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children ages 7-12 years who are able to assent to the procedures
- Able to complete the diaries which have been validated for use in this age range
- The history and medical evaluation reveal no organic reason for the abdominal pain
- The child has abdominal pain that meets the definition of FAP according to pediatric Rome IV
- Ability to understand study procedures and to comply with them for the entire length of the study
Key exclusion criteria (11 listed)
- Past bowel surgery
- Documented GI disorders (e.g., Crohn's disease)
- A serious chronic medical condition (e.g., diabetes)
- A weight and/or height < 2 SD for age
- 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: mentholAdministration of peppermint oil at one of two daily doses. | Drug | 540 mg, 900 mg |
Primary outcome
Pharmacokinetics of peppermint oil
Time frame: 2 weeks
Area under the curve
Gut Microbiome composition
Time frame: 2 weeks
Gut microbiome composition as determined by 16S sequencing as a consequence of the administration of peppermint oil at the two doses given.
Gut transit time
Time frame: 2 weeks
Gut transit time as a consequence of the administration of peppermint oil at the two doses given.
Gut contractility
Time frame: 2 weeks
Gut contractility as a consequence of the administration of peppermint oil at the two doses given.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- 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.
Robert 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 Baylor College of Medicine 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 6 inclusion and 11 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: withdrawn, as of the sponsor's last update on 11 Dec 2023. 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 was withdrawn before enrolling participants, so there are no results.
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 of peppermint oil (time frame: 2 weeks). The study lists 4 primary outcomes in all. 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 11 Dec 2023.