NL-OMON52287RecruitingPhase 3
Peppermint Oil for the treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT study - MINT-study
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Sint Antonius Ziekenhuis
- Enrollment
- 240
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 2 to 17 (—)
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
- •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
Investigators
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