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NCT06684470 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study of Diarrhea and IBS - Irritable Bowel Syndrome, sponsored by Mayo Clinic.

Recruiting
Registry status
Early Phase 1
Development phase
20
Enrollment target
1
Study location

NCT06684470: Recruiting Early Phase 1 study of Diarrhea and IBS - Irritable Bowel Syndrome, sponsored by Mayo Clinic.

NCT06684470 is a Early Phase 1 study of Diarrhea and IBS - Irritable Bowel Syndrome that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 20 participants, below the 156-participant average among 24 other Diarrhea trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06684470, a Early Phase 1 study of Diarrhea and IBS - Irritable Bowel Syndrome, is actively recruiting participants, sponsored by Mayo Clinic.

RECRUITING
Registry status
Early Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

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

Interventions

  • OTHER Placebo
  • DRUG Mirtazapine

Study Locations (1)

Florida

  • Mayo Clinic - Jacksonville

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-12-19
Est. Completion 2026-12-19
Phase Early Phase 1
Mayo Clinic

2,844 total trials

What NCT06684470 shows while recruiting

NCT06684470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 156-participant average among 24 other Diarrhea trials with a reported enrollment target (87% lower).

The record links to 2 conditions, with Diarrhea appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06684470 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT06684470 about?

NCT06684470 is a clinical study titled "Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator". 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, an...

What is the current status of trial NCT06684470?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2024-12-19. Estimated completion is 2026-12-19.

What conditions does trial NCT06684470 study?

This clinical trial studies the following conditions: Diarrhea, IBS - Irritable Bowel Syndrome.

What interventions are being tested in trial NCT06684470?

The interventions under investigation include: Placebo (OTHER), Mirtazapine (DRUG).

Who is sponsoring clinical trial NCT06684470?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06684470 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Diarrhea

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06684470's enrollment target sits among peer trials

20 23rd of 24 higher than 2 of 24 other Diarrhea trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diarrhea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06684470, the US trial registry maintained by the National Library of Medicine. NCT06684470 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.