Study to Treat Symptoms of Ibs With Diarrhea Using Combination Therapy of a Low-Fodmap Diet and a Neuromodulator

Overview

About this study

The purpose of this study is to treat symptoms of IBS with diarrhea using combination therapy of a low-FODMAP diet and a neuromodulator.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adults (ages 18-70).
  • Score of > 175 on the IBS-SSS questionnaire.
  • Must meet Rome IV criteria for IBS-D.
  • If subject is of reproductive capability a negative urine pregnancy test must be available prior to entering the study.
  • Ability to understand study procedures and to comply with them for the entire length of the study.

Exclusion Criteria:

  • Score of < 175 on the IBS-SSS.
  • Prior diagnoses of: known celiac disease, small intestinal bacterial overgrowth, inflammatory bowel disease, or microscopic colitis.
  • Ongoing significant anxiety or depression.
  • A history of a known side effect to mirtazapine.
  • Prior treatment with a low FODMAP diet or mirtazapine without clinical benefit.
  • Active alcohol or drug abuse.
  • Inability to read or understand the consent form.
  • Any other medical or psychological reason that would prevent active participation in a research study.
  • Pregnant females.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/11/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Brian Lacy, M.D., Ph.D.

Open for enrollment

Contact information:

Wendi Lehman

Lehman.Wendi@mayo.edu

More information

Publications

Publications are currently not available