A Phase 1 interventional study of Peppermint oil in Abdominal Pain, sponsored by Robert Shulman, M.D.. Completed at 1 site in United States. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Robert Shulman, M.D. · Phase 1, Interventional, and Treatment
Among 158 studies in Abdominal Pain with a site in United States — 23 open to participants now, 24 under way, 1 of them phase 3. Abdominal Pain · United States.
Among the 158 studies in Abdominal Pain with a site in United States, this one is the 92nd largest by enrollment of the 133 interventional ones that give a count, is one of 10 that started in 2017, is one of 7 in phase 1, and was the 90th registered.
387 studies on the registry are indexed under Abdominal Pain; 58 are open to participants now.
Browse Abdominal Pain studies →23 of the 158 studies in Abdominal Pain with a site in United States are open now. Recruiting first, the newest first:
Columbia University · Sites in United States
Ages 6–17
Baylor College of Medicine · Sites in United States
Ages 7–12
Case Comprehensive Cancer Center · Sites in United States
Ages 18+
Kiwi Health Inc · Sites in United States
Ages 18+ · Healthy volunteers
Ohio State University · Sites in United States
Ages 18–80
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 33 Abdominal Pain studies recruiting now, 13 (39%) set no upper age limit and 17 (52%) stop at 75 or younger; 10 take children under 18; 7 take healthy volunteers.
This study: 7 Years to 12 Years · all sexes · no healthy volunteers.
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158 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 31 · Phase 3 15 · Phase 4 11
First in 1996; this study’s year is marked. 10 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 70 across 290 interventional studies indexed under Abdominal Pain.
Median enrollment 61 across the 133 interventional studies, 94 across the 24 observational. Of the 119 that completed or were terminated, 38 (32%) have results posted.
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40 of 158 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Robert Shulman, M.D. as lead sponsor.
Robert Shulman, M.D. has 1 study filed under Abdominal Pain — fewer than ten, so there is no comparison to draw.
10 of the studies in Abdominal Pain with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07174609Johns Hopkins UniversityScrambler Therapy in Chronic Pancreatitis | 2026-12-01 |
| NCT07649720AnX Robotica Corp.NaviCam Patency Capsule to Verify Gastrointestinal Patency | 2026-12-15 |
| NCT06647615Mayo ClinicA Pilot Study to Assess the Safety, Tolerability, and Efficacy of Virtual Reality for the Treatment of Abdominal Pain in Quiescent Crohn's Disease | 2026-12-31 |
| NCT07117032Case Comprehensive Cancer CenterSimulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy (SBRT) in Participants With Cancer-Related Celiac Pain | 2027-02 |
| NCT06706778Yale UniversityThe Mechanism Underlying the Analgesic Effect of the Music of IBS Pain | 2027-03 |
Add all 10 to your calendar (.ics) → With an account.
Among the 158 studies in Abdominal Pain with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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Exclusion Criteria:
180 mg of peppermint oil
Drug: Peppermint oil
360 mg of peppermint oil
Drug: Peppermint oil
540 mg of peppermint oil
Drug: Peppermint oil
Three doses of peppermint oil will be investigated: 180, 360, 540 mg; i.e. three arms.
Also known as: Enteric coated peppermint oil capsules
Pharmacokinetics
Area under the curve
Time frame: 24 hours
Contractility
Number and amplitude of gut contractions as measured by SmartPill
Time frame: 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.
Time frame: Prior to and during peppermint oil treatment
Motility
Gut transit time as measured by SmartPill
Time frame: Prior to and during peppermint oil treatment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Mar 2019, 17 months.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Peppermint oil