Novel Pilot Study to Treat Symptoms of IBS with Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator

Description

The purpose of this research is to study the added benefit of treating IBS symptoms with a medication called mirtazapine in treating IBS symptoms when paired with a low-FODMAP diet compared to a low-FODMAP diet alone. FODMAP stands for fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. These are short-chain carbohydrates that can cause digestive distress in some people. You have been asked to take part in this research because you have symptoms of diarrhea-predominant irritable bowel syndrome that may respond to treatment with a combination of a medication called mirtazapine and a low-FODMAP diet.

Conditions

IBS - Irritable Bowel Syndrome, Diarrhea

Talk to us

Study Overview

On this page

Study Details

Study overview

The purpose of this research is to study the added benefit of treating IBS symptoms with a medication called mirtazapine in treating IBS symptoms when paired with a low-FODMAP diet compared to a low-FODMAP diet alone. FODMAP stands for fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. These are short-chain carbohydrates that can cause digestive distress in some people. You have been asked to take part in this research because you have symptoms of diarrhea-predominant irritable bowel syndrome that may respond to treatment with a combination of a medication called mirtazapine and a low-FODMAP diet.

Novel Pilot Study to Treat Symptoms of IBS with Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator

Novel Pilot Study to Treat Symptoms of IBS with Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator

Condition
IBS - Irritable Bowel Syndrome
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Mayo Clinic, Jacksonville, Florida, United States, 32224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants must meet all of the inclusion criteria to participate in this study:
  • * 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
  • * All candidates meeting any of the below exclusion criteria at baseline will be excluded from study participation:
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Brian E Lacy, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2025-12-19