Home › Irritable Bowel Syndrome › NCT06684470

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

Who can join

Ages 18 to 70 · All sexes

Inclusion 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

Exclusion Criteria:

* 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

About the study

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.

What is being tested

• Mirtazapine (drug)
• Placebo (other)

Sponsor: Mayo Clinic · Participants: 20 · Started: Dec 19, 2024

Contact the study team

• Jessica C Petrov, MD · Phone: 904-953-2000

Official record on ClinicalTrials.gov — NCT06684470

Locations in the U.S.

Conditions

• Irritable Bowel Syndrome
• Diarrhea

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.