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Enteric-Coated Peppermint Oil Versus Standard Antispasmodic in SLC6A4 (5-HTTLPR) Carriers With Irritable Bowel Syndrome.

NCT06914921 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2025-04-23

No results posted yet for this study

Summary

This study is a non-inferiority, double-blind, randomized controlled trial comparing enteric-coated peppermint oil with a standard antispasmodic (e.g., mebeverine) in adult IBS patients who carry at least one "S" allele in the SLC6A4 (5-HTTLPR) polymorphism. The primary goal is to see whether peppermint oil provides symptom relief (measured by IBS severity scores) that is not worse than the antispasmodic by more than a predefined margin (30 points on the IBS-SSS). Secondary goals include evaluating differences in abdominal pain, stool patterns, quality of life, and adverse event profiles, with a focus on peppermint oil's tolerability. About 224 participants (112 per arm) will be enrolled, with allowances for dropout, to detect non-inferiority at 80% power. After 12 weeks of treatment, results will inform whether peppermint oil is a viable, well-tolerated alternative to standard antispasmodics, especially in patients with heightened GI sensitivity linked to the SLC6A4 polymorphism.

Conditions

  • Irritable Bowel Syndrome (IBS)

Interventions

DIETARY_SUPPLEMENT

Peppermint Oil

Enteric-coated peppermint oil capsules (\~180 mg total peppermint oil/ capsule) to ensure release in the small intestine. 1 capsule three times daily, 30 minutes before meals, for 12 weeks.

DRUG

A standard antispasmodic

A standard antispasmodic (e.g., mebeverine 135 mg). 1 tablet three times daily, before meals, for 12 weeks.

Sponsors & Collaborators

  • Center for New Medical Technologies, Novosibirsk, Russia

    collaborator OTHER

  • S.LAB (SOLOWAYS)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-04
Primary Completion
2025-01-17
Completion
2025-02-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06914921 on ClinicalTrials.gov