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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 19, 2024

Primary Completion Date

December 19, 2025

Study Completion Date

December 19, 2025

Conditions
IBS - Irritable Bowel SyndromeDiarrhea
Interventions
DRUG

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.

OTHER

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.

Trial Locations (1)

32224

RECRUITING

Mayo Clinic, Jacksonville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER