NCT06684470 Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator
| NCT ID | NCT06684470 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Mayo Clinic |
| Condition | IBS - Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2026-12-19 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-12-19 with a primary completion date of 2026-12-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Brian E Lacy, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06684470 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying IBS - Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06684470 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06684470 currently recruiting?
Yes, NCT06684470 is actively recruiting participants. Contact the research team at Petrov.Jessica@mayo.edu for enrollment information.
Where is the NCT06684470 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT06684470 clinical trial?
NCT06684470 is sponsored by Mayo Clinic. The principal investigator is Brian E Lacy, MD at Mayo Clinic. The trial plans to enroll 20 participants.