Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMayo Clinic
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Mirtazapine
- Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov