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

NCT05799053 | Completed Phase 3

• 1 other identifier: NL78304.100.21
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• Abdominal pain intensity response rate after 8 weeks of treatment

  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.

  8 weeks

Secondary Outcomes (17)

• Change in pain duration

  4 weeks, 8 weeks, 12 weeks

• Change in pain frequency

  4 weeks, 8 weeks, 12 weeks

• Change in abdominal pain intensity

  4 weeks, 8 weeks, 12 weeks

• Change in Quality of Life

  8 weeks

• Change in depression and anxiety score

  8 weeks

Study Arms (3)

Peppermint oil capsules (Tempocol®)

EXPERIMENTAL

Enteric-coated capsule containing 182mg of Peppermint Oil that release the oil in the small intestine, to be taken orally. Age: 8-11 years old: 2 times daily for 8 weeks, if needed upped to 3 times daily after 4 weeks Age: 12-18: 3 times daily for 8 weeks, if needed upped to 3 times two capsules daily after 4 weeks

Drug: Small intestinal release peppermint oil

Placebo

PLACEBO COMPARATOR

Capsule containing microcrystalline cellulose, to be taken orally. Age: 8-11 years old: 2 times daily for 8 weeks, if needed upped to 3 times daily after 4 weeks Age: 12-18: 3 times daily for 8 weeks, if needed upped to 3 times two capsules daily after 4 weeks

Drug: Placebo

Peppermint sweets (Wilhelmina®)

EXPERIMENTAL

Wilhelmina® peppermints contain 9.2 mg of Menthae Piperitae Aetheroleum (peppermint oil), and 18.4 Kcal per mint and are to be taken orally. Age: 8-11 years old: 2 times daily for 8 weeks, if needed upped to 3 times daily after 4 weeks Age: 12-18: 3 times daily for 8 weeks, if needed upped to 3 times two capsules daily after 4 weeks

Drug: Peppermint sweets

Interventions

Small intestinal release peppermint oil DRUG

Tempocol®, a gastric acid resistant (enteric-coated) capsule containing 182mg of Menthae Piperitae Aetheroleum (peppermint oil), is currently registered as an over the counter prescription drug on the Dutch market for treatment of abdominal pain, discomfort or flatulence.

Also known as: Peppermint oil, Menthae piperitae aetheroleum, Tempocol®, A03AX15

Peppermint oil capsules (Tempocol®)

Peppermint sweets DRUG

Wilhelmina® peppermints contain 9.2 mg of Menthae Piperitae Aetheroleum (peppermint oil), and 18.4 Kcal per mint and are to be taken orally.

Also known as: Wilhelmina®

Peppermint sweets (Wilhelmina®)

Placebo DRUG

Capsule containing microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (3)

De KinderKliniek

Almere Stad, Flevoland, 1315 RC, Netherlands

Location

Amphia Hospital

Breda, North Brabant, 4818 CK, Netherlands

Location

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Drug-Related Side Effects and Adverse Reactions

Interventions

peppermint oil

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Chemically-Induced Disorders

Study Officials

• Arine Vlieger, MD, PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Peppermint oil capsules and placebo are double blinded, peppermint sweets are open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Patients are randomized in three groups: 1) peppermint oil capsules, 2) placebo), peppermint sweets

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: April 5, 2023
• Study Start: May 12, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: May 30, 2025

Record last verified: 2024-04

Locations

NL (3)