Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator
Mayo Clinic
20 participants
Dec 19, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria9
- 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
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Interventions
mirtazapine will be told to use 1 pill 1 hour before bedtime for the first week (7.5 mg po q.h.s.), 2 pills before bedtime during the second week of therapy (15 mg po q.h.s.), 3 pills (22.5 mg po q.h.s.) 1 hour before bedtime for the third week, and 4 pills (30 mg po q.h.s.) 1 hour prior to bedtime for the remainder of the study.
Placebo will be told to use 1 pill 1 hour before bedtime for the first week (7.5 mg po q.h.s.), 2 pills before bedtime during the second week of therapy (15 mg po q.h.s.), 3 pills (22.5 mg po q.h.s.) 1 hour before bedtime for the third week, and 4 pills (30 mg po q.h.s.) 1 hour prior to bedtime for the remainder of the study.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06684470