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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT06684470
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Diarrhea
  • IBS - Irritable Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
    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.

Study Details

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.

Key Dates

Start date
Dec 19, 2024
Status verified
Dec 2025
Primary completion
Dec 19, 2026
Completion
Dec 19, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Resolution of Irritable Bowel Syndrome [ Time Frame: 49 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicJacksonvilleFlorida32224
Jessica C Petrov, M.D.
[email protected]
904-953-6970
Brian Lacy, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic· Jacksonville, FL

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