Health TrialsbyHealthPanel

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

ConditionsIBS - Irritable Bowel SyndromeDiarrhea
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMayo Clinic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mirtazapine

    Drug

    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

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Mirtazapine GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Resolution of Irritable Bowel Syndrome

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

Time frame
49 days
2

Abdominal Pain Score

Assess improvement in abdominal pain using a numerical rating system

Time frame
49 days
3

Stool Form Scale

Assess improvement in diarrhea using the Bristol stool form scale

Time frame
49 days
4

Mayo Bloating Scale

Assess response to bloating using a validated Mayo bloating questionnaire

Time frame
49 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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