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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Mayo Clinic
RECRUITING
Jacksonville
Contact Information
Primary
Jessica C Petrov, MD
Petrov.Jessica@mayo.edu
904-953-2000
Time Frame
Start Date: 2024-12-19
Estimated Completion Date: 2025-12-19
Participants
Target number of participants: 20
Treatments
Experimental: Mirtazapine Group
Subjects will present at Mayo Clinic through a doctor's appointment and a diagnosis of irritable bowel syndrome will be receiving mirtazapine by pill form.
Placebo_comparator: Placebo Group
Subjects will present at Mayo Clinic through a doctor's appointment and a diagnosis of irritable bowel syndrome will be receiving placebo by pill form.
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov