Trial · NCT05799053
Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study
NCT05799053, Phase 3, Completed, St. Antonius Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study. Trials, record NCT05799053. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05799053
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study
- NCT number
- NCT05799053
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 228 participants, actual
- Lead sponsor
- St. Antonius Hospital
- Conditions
- Irritable Bowel Syndrome, Functional Abdominal Pain Syndrome, Child, Adolescent, Therapeutics, Adverse Drug Event
- Interventions
- Small intestinal release peppermint oil, Peppermint sweets, Placebo
- First posted
- 2023-04-05
- Last updated
- 2025-05-30
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Abdominal pain intensity response rate after 8 weeks of treatment | 8 weeks | The proportion of patients with ≥ 30% reduction of their abdominal pain intensity after 8 weeks of therapy compared to baseline. This will be assessed by a smartphone diary app, on which patients record daily at the end of the day the intensity of their abdominal pain during a period of 7 consecutive days using a 10 point Likert scale/Wong-Baker faces scale. A score of 0 correlates with no pain and a score of 10 correlates with the worst imaginable pain. The intensity scores of 7 days will be summed up. |
| Secondary | Change in pain duration | 4 weeks, 8 weeks, 12 weeks | Abdominal pain duration will be scored in minutes of abdominal pain per day during 7 consecutive days after 8 weeks of therapy compared to baseline |
| Secondary | Change in pain frequency | 4 weeks, 8 weeks, 12 weeks | Abdominal pain frequency will be scored as the average amount of days with pain during 7 consecutive days after 8 weeks of therapy compared to baseline |
| Secondary | Change in abdominal pain intensity | 4 weeks, 8 weeks, 12 weeks | Abdominal pain intensity will be scored using a 10-point Wong-Baker faces scale during 7 consecutive days after 8 weeks of therapy compared to baseline |
| Secondary | Change in Quality of Life | 8 weeks | Change in quality of live will be measured with the PedsQL after 8 weeks of therapy compared to baseline |
| Secondary | Change in depression and anxiety score | 8 weeks | Depression and anxiety scores are measured by the Revised Anxiety and Depression Scale-short version (RCADS-25) after 8 weeks of therapy compared to baseline |
| Secondary | School absences during the treatment | 4 weeks, 8 weeks, 12 weeks | Hours of school absence in the previous week are measured. |
| Secondary | Use of pain rescue medication during the treatment | 4 weeks, 8 weeks, 12 weeks | Use of pain rescue medication like paracetamol or NSAIDs |
| Secondary | Expectancy of treatment | 0 weeks | expectations of both parents separately of the treatment on a scale of 0 (no improvement) to 10 (very much improved) |
| Secondary | Expectancy of treatment | 0 weeks | the child's expectations of the treatment on a scale of 0 (no improvement) to 10 (very much improved) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41610933 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05799053
GET https://conductscience.org/api/trials/v1/NCT05799053/registered