Clinical trial NCT05799053: Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study
Official title: Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Functional Abdominal Pain Syndrome
Child
Adolescent
Therapeutics
Adverse Drug Event
Keywords: Peppermint oil
Irritable Bowel Syndrome
Functional Abdominal Pain - Not Otherwise Specified
Paediatrics
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 228
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized in three groups: 1) peppermint oil capsules, 2) placebo), peppermint sweets
Primary purpose: TREATMENT

Brief summary: Peppermint oil has shown to be effective in the treatment of Irritable Bowel Syndrome (IBS) symptoms in adults. Few studies of low quality are performed in an paediatric setting. Therefore, the investigators will conduct a multicenter randomized, placebo controlled trial to investigate the effects of an eight-week peppermint oil treatment in paediatric IBS or Functional Abdominal Pain - Not otherwise specified (FAP-NOS) patients.

Detailed description: The objective of the MINT study is to investigate the effectiveness of peppermint oil capsules compared to placebo capsules in reducing abdominal pain intensity in children with IBS or FAP-NOS. In addition, we evaluate the effect of peppermint oil capsules compared to placebo capsules on other disease-related outcome measures such as anxiety \& depression, quality of life, absenteeism from school, and healthcare costs. The second aim is to explore the effectiveness of regular mints in reducing abdominal pain intensity compared to peppermint oil capsules and placebo capsules and the effect of mints on secondary outcome parameters.

Eligibility criteria: Inclusion Criteria:

* Children aged between 8 years and 18 years
* Diagnosis of IBS or FAP-NOS according to the Rome IV criteria. According to these criteria, organic disorders will be ruled out after routine laboratory testing initiated by their general practitioner or treating physician as part of standard of care. In patients without alarm symptoms only celiac screening (anti-transglutaminase antibodies and IgA), and faecal calprotectin are necessary.37 In patients with diarrhea faecal testing for Giardia Lambliae will be added. If alarm symptoms are present, further diagnostic testing (like a full blood count, CRP, liver tests or an ultrasound) to rule out an organic disorder, is left to the discretion of the treating physician.
* An average daily pain rate of ≥ 3 of 10 on the Wong Baker Faces Pain Scale (This is a validated pain scale to measure pain intensity).

Informed Consent by both parents and by children aged ≥ 12 years. No informed consent from parents is necessary for children \>16 years.

Exclusion Criteria:

* Current treatment by another health care professional for abdominal symptoms
* Previous use of peppermint oil for these 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

Primary outcomes:
measure: Abdominal pain intensity response rate after 8 weeks of treatment
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in pain duration
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Change in pain frequency
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Change in abdominal pain intensity
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Change in Quality of Life
timeFrame: 8 weeks
measure: Change in depression and anxiety score
timeFrame: 8 weeks
measure: School absences during the treatment
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Use of pain rescue medication during the treatment
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Expectancy of treatment
timeFrame: 0 weeks
measure: Expectancy of treatment
timeFrame: 0 weeks
measure: Change in defecation pattern
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Adequate relief
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Health status
timeFrame: 8 weeks
measure: Costs
timeFrame: 8 weeks, 12 weeks
measure: Safety of peppermint oil
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Ease of use of peppermint oil capsules, placebo capsules or peppermint sweets
timeFrame: 8 weeks
measure: Taste of peppermint oil capsules, placebo capsules or peppermint sweets
timeFrame: 8 weeks
measure: Placebo genes
timeFrame: 0 weeks
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: De KinderKliniek
state: Flevoland
city: Breda
country: Netherlands
facility: Amphia Hospital
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
Study officials:
affiliation: St. Antonius Hospital
name: Arine Vlieger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: