drugset / Trial / NCT05799053

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

NCT05799053 ↗

Phase 3 Completed 228 enrolled St. Antonius Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-05-12
Primary completion
2024-11-30
Completion
2024-11-30

Outcome

Missed primary endpoint

paper Neither peppermint oil nor peppermint sweets were superior to placebo in treating pediatric IBS and FAP-NOS. PMID 41610933 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Peppermint oil Other / unclassified 182 mg Oral
Subject Wilhelmina® Unknown 9.2 mg Oral