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

Launched by MAYO CLINIC · Nov 9, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a potential new treatment for people suffering from diarrhea-predominant irritable bowel syndrome (IBS-D). The study is looking to see if combining a medication called mirtazapine with a special diet known as a low-FODMAP diet can help improve IBS symptoms more effectively than just the diet alone. The low-FODMAP diet is designed to limit certain carbohydrates that can upset digestion.

To participate, individuals need to be between 18 and 70 years old and have a specific score on an IBS symptom questionnaire, indicating their condition is significant. They should also meet certain medical criteria to ensure the treatment is safe for them. If you join the study, you'll be guided through the treatment process and monitored for any changes in your symptoms. It's important to know that certain health conditions or past treatments may make you ineligible for this trial. If you think you might qualify, talk to your healthcare provider for more information.

Gender

ALL

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