Functional abdominal pain Irritable Bowel Syndrome
Conditions
Interventions
Peppermint oil capsules 182 mg 2 d.d.1 capsules (8-11 years) or 3 d.d. 1
capsule (12-18 years) versus placebo capsules versus regular mints 2-3 times 1
day for 8 weeks
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: Children aged between 8 and 18 years Diagnosos of IBS or FAP-NOS according to the Rome IV-criteria. Patients are required to have an average daily pain rate of >=2 on the Wong-Baker Faces Pain Scale
Exclusion criteria
Exclusion criteria: Current treatment by another health care professional for abdominal symptoms Previous use of peppermint oil for abdominal complaints Known hypersensitivity to mints or peppermint oil Gastrointestinal blood loss Recurrent or unexplained fevers Decreased growth velocity History of previous abdominal surgeries in the past 3 months Significant chronic health condition requiring specialty care (e.g., lithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially impact the child*s ability to participate or confound the results of the study Known concomitant organic gastrointestinal disease Current use of drugs which influence gastrointestinal motility, such as erythromycin, azithromycin, butyl scopolamine, domperidone, mebeverine and Iberogast. If laxatives are being used (in patients with IBS-C) they can continue using them during the study. Current use of proton-pump inhibitors Insufficient knowledge of the Dutch language Pregnancy or current lactation. Women with childbearing potential must have a negative urine pregnancy test within 7 days prior to first dose of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the percentage of children with >30% reduction in abdominal pain intensity after 8 weeks of treatment from baseline. Abdominal pain intensity is measured daily for 7 consecutive days using an abdominal pain app. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are other recently internationally defined outcome measures for trials in children with chronic abdominal pain: degree of reduction in pain frequency and pain intensity, percentage of patients with an adequate improvement in complaints, school absenteeism hours, quality of life, feelings of anxiety & depression, defecation pattern, taste, ease of use and side effects of the treatment. In addition, genetic polymorphisms associated with susceptibility to placebos are investigated and related to both primary and secondary outcome measures. | — |
Countries
Netherlands
Outcome results
None listed