Early Phase 1 Irritable Bowel Syndrome Trial, Recruiting NCT06684470 Sponsor: Mayo Clinic Condition: Irritable Bowel Syndrome
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Early Phase 1 Irritable Bowel Syndrome Trial, Recruiting

NCT06684470
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 70 years old
  • You have scored above 175 on a questionnaire that measures the severity of IBS symptoms (called the IBS-SSS)
  • You have been diagnosed with a specific type of IBS that mainly involves diarrhea, according to recognised medical guidelines (called Rome IV criteria for IBS-D)
  • If you are capable of becoming pregnant, you must have a negative pregnancy test before joining the study
  • You are able to understand what the study involves and are willing and able to follow the study procedures for the full duration

Who may not be able to join:

  • You scored 175 or below on the IBS symptom severity questionnaire
  • You have previously been diagnosed with celiac disease, small intestinal bacterial overgrowth, inflammatory bowel disease, or microscopic colitis
  • You are currently experiencing significant anxiety or depression
  • You have had a known bad reaction or side effect to a medication called mirtazapine in the past
  • You have already tried a low FODMAP diet or mirtazapine and they did not help your symptoms
  • You are currently struggling with alcohol or drug misuse
  • You are unable to read or understand the consent form
  • You are pregnant
  • You have any other medical or mental health condition that would prevent you from fully taking part in a research study (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Brian E Lacy, MD, Mayo Clinic

Phone: 904-953-2000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
19 December 2024
Est. completion
19 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Resolution of Irritable Bowel Syndrome; Abdominal Pain Score; Stool Form Scale; Mayo Bloating Scale

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov