Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator
Recruiting now · Early Phase 1 · Has a placebo group
Conditions studied: IBS - Irritable Bowel Syndrome, Diarrhea
In brief
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.
Key facts
- Study ID
- NCT06684470
- Run by
- Mayo Clinic
- People needed
- 20
- Starts
- 2024-12-19
- Expected to finish
- 2026-12-19
- Last updated by the study team
- 2025-12-18
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic — Jacksonville, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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