Effects of Open-label vs Double-blind Treatment in IBS

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Placebo Effect; Placebos; Peppermint Oil
• Interventions: Dietary Supplement: peppermint oil; Drug: placebo

• Registration Number: NCT02802241
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-16
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Results First Submitted: 2020-07-20
• Results First Submitted QC: 2020-09-03
• Results First Posted: 2020-09-04
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• Meet Rome IV diagnostic criteria for IBS

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
double-blind peppermint oil	peppermint oil	-
double-blind placebo	placebo	-
open-label placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks.	6 weeks	Score ranges from 0-500, 0 indicates no symptoms, 500 indicates worst possible symptoms

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States