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

RecruitingEARLY Phase 1Ages 18 Years - 70 YearsAllMayo Clinic
NCT06684470 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Mirtazapine
  • Placebo
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Where

1 site
Mayo Clinic
Jacksonville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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