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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Brian E Lacy, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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