Peppermint Oil for the treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 240

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
treatment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the percentage of children with >30% reduction<br /><br>in abdominal pain intensity after 8 weeks of treatment from baseline. Abdominal<br /><br>pain intensity is measured daily for 7 consecutive days using an abdominal pain<br /><br>app.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are other recently internationally defined outcome<br /><br>measures for trials in children with chronic abdominal pain: degree of<br /><br>reduction in pain frequency and pain intensity, percentage of patients with an<br /><br>adequate improvement in complaints, school absenteeism hours, quality of life,<br /><br>feelings of anxiety & depression, defecation pattern, taste, ease of use and<br /><br>side effects of the treatment. In addition, genetic polymorphisms associated<br /><br>with susceptibility to placebos are investigated and related to both primary<br /><br>and secondary outcome measures.</p><br>