Status:
COMPLETED
Enteric-Coated Peppermint Oil Versus Standard Antispasmodic in SLC6A4 (5-HTTLPR) Carriers With Irritable Bowel Syndrome.
Lead Sponsor:
S.LAB (SOLOWAYS)
Collaborating Sponsors:
Center for New Medical Technologies, Novosibirsk, Russia
Conditions:
Irritable Bowel Syndrome (IBS)
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 l...
Detailed Description
This double-blind, parallel-group, non-inferiority RCT will randomize \~250 adults (18-65 y) who meet Rome IV criteria for IBS and carry at least one short 5-HTTLPR (SLC6A4) allele to enteric-coated p...
Eligibility Criteria
Inclusion
- Adults aged 18-65 years.
- Diagnosis of Irritable Bowel Syndrome by Rome IV criteria, with at least moderate severity (IBS-SSS ≥ 175).
- SLC6A4 genotyping confirms at least one S allele (SS or SL).
- Able and willing to provide informed consent and comply with study procedures.
Exclusion
- L/L genotype of 5-HTTLPR.
- Known organic GI diseases (e.g., IBD, celiac disease).
- Severe/unstable comorbidities (e.g., cardiac, hepatic, or renal dysfunction).
- Use of peppermint oil, antispasmodics, or investigational drugs within 30 days prior to enrollment.
- . Known hypersensitivity to peppermint or mebeverine.
- Pregnancy or breastfeeding.
- Significant psychiatric illness that, in the investigator's judgment, might interfere with participation.
Key Trial Info
Start Date :
February 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT06914921
Start Date
February 4 2024
End Date
February 1 2025
Last Update
April 23 2025
Active Locations (1)
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1
Center for New Medical Technologirs
Novosibirsk, Russia, 630090