Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator
NCT ID: NCT06684470
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
20 participants
INTERVENTIONAL
2024-12-19
2026-12-19
Brief Summary
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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.
Detailed Description
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Improvement in anxiety and any other descriptive information as provided by patients including patients reporting impression of overall severity of symptoms at the beginning, middle, and end of study.
Irritable bowel syndrome (IBS) is a common gastrointestinal (GI) disorder that affects up to 10% of the United States adult population. IBS is characterized by recurrent abdominal pain and altered bowel habits, diagnosed using the Rome IV criteria. Approximately one-third of all IBS patients are classified as having IBS with diarrhea (IBS-D), which has no validated treatment algorithm. The American College of Gastroenterology IBS guideline recommends the low-FODMAP (fermentable oligo-, di-, monosaccharide, and polyol) diet as a safe and modestly effective treatment. An analysis of 7 randomized, controlled trials found that the low-FODMAP diet was associated with an improvement in global IBS symptoms. However, despite following the low-FODMAP diet, many patients have persistent abdominal pain, which can be difficult to treat. The mechanisms underlying chronic abdominal pain in patients with IBS are unknown, although visceral and central hypersensitivity are thought to play a role. No medication is FDA-approved for the treatment of abdominal pain in IBS. Mirtazapine is an atypical antidepressant that acts on several classes of receptors. In a small open-label study mirtazapine improved IBS-D symptoms, including abdominal pain.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Mirtazapine
mirtazapine will be told to use 1 pill 1 hour before bedtime for the first week (7.5 mg po q.h.s.), 2 pills before bedtime during the second week of therapy (15 mg po q.h.s.), 3 pills (22.5 mg po q.h.s.) 1 hour before bedtime for the third week, and 4 pills (30 mg po q.h.s.) 1 hour prior to bedtime for the remainder of the study.
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.
Placebo
Placebo will be told to use 1 pill 1 hour before bedtime for the first week (7.5 mg po q.h.s.), 2 pills before bedtime during the second week of therapy (15 mg po q.h.s.), 3 pills (22.5 mg po q.h.s.) 1 hour before bedtime for the third week, and 4 pills (30 mg po q.h.s.) 1 hour prior to bedtime for the remainder of the study.
Interventions
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Mirtazapine
mirtazapine will be told to use 1 pill 1 hour before bedtime for the first week (7.5 mg po q.h.s.), 2 pills before bedtime during the second week of therapy (15 mg po q.h.s.), 3 pills (22.5 mg po q.h.s.) 1 hour before bedtime for the third week, and 4 pills (30 mg po q.h.s.) 1 hour prior to bedtime for the remainder of the study.
Placebo
Placebo will be told to use 1 pill 1 hour before bedtime for the first week (7.5 mg po q.h.s.), 2 pills before bedtime during the second week of therapy (15 mg po q.h.s.), 3 pills (22.5 mg po q.h.s.) 1 hour before bedtime for the third week, and 4 pills (30 mg po q.h.s.) 1 hour prior to bedtime for the remainder of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Brian Lacy
Principal Investigator
Principal Investigators
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Brian E Lacy, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Jacksonville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Jessica C Petrov, M.D.
Role: primary
Other Identifiers
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23-011874
Identifier Type: -
Identifier Source: org_study_id