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

Beth Israel Lahey Health

Status: Completed

Conditions: Irritable Bowel Syndrome; Peppermint Oil; Placebos; Placebo Effect

Treatments: Drug: placebo; Dietary Supplement: peppermint oil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02802241

R01AT008573 (U.S. NIH Grant/Contract)

2015P000282

Details and patient eligibility

About

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

Enrollment: 340 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Meet Rome IV diagnostic criteria for IBS

Trial design

340 participants in 4 patient groups

open-label placebo

Experimental group

Treatment:

Drug: placebo

double-blind placebo

Experimental group

Treatment:

Drug: placebo

double-blind peppermint oil

Experimental group

Treatment:

Dietary Supplement: peppermint oil

no additional treatment

No Intervention group