Pilot Study for IBS with Diarrhea Using Mirtazapine and Low-FODMAP Diet

This study is looking at whether combining a low-FODMAP diet (a diet that limits certain carbohydrates that can cause digestive issues) with a medication called mirtazapine can better help people with Irritable Bowel Syndrome with Diarrhea (IBS-D) compared to just the low-FODMAP diet alone. Researchers want to see if this combination improves symptoms like abdominal pain and diarrhea. You might be able to join if you are between 18 and 70 years old, have IBS-D based on specific criteria, and score above 175 on the IBS-SSS questionnaire. The study will measure how much your IBS symptoms, abdominal pain, and stool form improve after 49 days. The current status of this study is unclear, and it plans to enroll 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
Participants will be told to use mirtazapine or a placebo, starting with 1 pill before bedtime for the first week, increasing to 2 pills in the second week, 3 pills in the third week, and 4 pills in the fourth week. Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, such as resolution of IBS, abdominal pain score, and stool form scale, will be measured at 49 days.

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NCT06684470

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

Recruiting
EARLY_PHASE1Ages 18–70InterventionalTreatment
Mayo Clinic
~20 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:MirtazapinePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Resolution of Irritable Bowel Syndrome
Measured over 49 days
+3 more outcomes measured
IBS - Irritable Bowel Syndrome
Diarrhea
1 sites across 1 states
Florida1
  • Brian E Lacy, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

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

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
  • Resolution of Irritable Bowel Syndrome49 days

    Evaluate global improvement in IBS symptoms using the validated IBS-SSS

  • Abdominal Pain Score49 days

    Assess improvement in abdominal pain using a numerical rating system

  • Stool Form Scale49 days

    Assess improvement in diarrhea using the Bristol stool form scale

  • Mayo Bloating Scale49 days

    Assess response to bloating using a validated Mayo bloating questionnaire