Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator (NCT06684470)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (11 items).
Location: Mayo Clinic — Jacksonville, Florida
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Mayo Clinic — Jacksonville, Florida
📞 Contact the Study Coordinator
Phone: (904) 953-2000
Email: Petrov.Jessica@mayo.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in IBS - Irritable Bowel Syndrome
- Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS) — Riviera Beach, Florida
- Psilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS) — New York, New York
- Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease — Redwood City, California
- Evaluating the Impact of Including Virtual Dietary Education Within an Electronic Irritable Bowel Syndrome Pathway — Halifax, N.S.
Explore by condition: All IBS - Irritable Bowel Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.