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

Overview

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

Full Title of Study: “Effects of Open-label vs Double-blind Treatment in IBS.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
  • Study Primary Completion Date: January 2019

Interventions

  • Drug: placebo
  • Dietary Supplement: peppermint oil

Arms, Groups and Cohorts

  • Experimental: open-label placebo
  • Experimental: double-blind placebo
  • Experimental: double-blind peppermint oil
  • No Intervention: no additional treatment

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Meet Rome IV diagnostic criteria for IBS

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beth Israel Deaconess Medical Center
  • Collaborator
    • National Center for Complementary and Integrative Health (NCCIH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Judy Nee, Assistant Professor of Medicine – Beth Israel Deaconess Medical Center

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