Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMA… (NCT06684470) | Clinical Trial Compass
RecruitingEarly Phase 1
Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator
United States20 participantsStarted 2024-12-19
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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