NCT05799053View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

228

Participants

Timeline

Start Date

May 12, 2022

Primary Completion Date

November 30, 2024

Study Completion Date

November 30, 2024

Conditions
Irritable Bowel SyndromeFunctional Abdominal Pain SyndromeChildAdolescentTherapeuticsAdverse Drug Event
Interventions
DRUG

Small intestinal release peppermint oil

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.

DRUG

Peppermint sweets

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

DRUG

Placebo

Capsule containing microcrystalline cellulose

Trial Locations (3)

1315 RC

De KinderKliniek, Almere Stad

4818 CK

Amphia Hospital, Breda

1105 AZ

Amsterdam UMC, Amsterdam

All Listed Sponsors
lead

St. Antonius Hospital

OTHER