Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator
Key facts
- Where
- Jacksonville, United StatesSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06684470, who can take part
Where in United States
- Mayo ClinicJacksonville, United StatesContact: Jessica C Petrov, M.D.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Mayo Clinic
- Trial code
- NCT06684470
- Record updated
- 18 December 2025
- Original 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.Read full original descriptionShow less
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.
Inclusion: 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: 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.