Irritable Bowel Syndrome Trial, Recruiting NCT05796388 Sponsor: Mayo Clinic Condition: Irritable Bowel Syndrome
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Irritable Bowel Syndrome Trial, Recruiting

NCT05796388
Recruiting Not Applicable

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:

  • Adults between 18 and 70 years old (men and women) who have been diagnosed with a type of irritable bowel syndrome that involves mainly constipation (IBS-C), based on a standard set of medical guidelines called Rome IV criteria.
  • People whose IBS significantly affects their quality of life, shown by scoring below 65 on a standard IBS quality-of-life questionnaire (meaning their daily life is at least moderately impacted by their symptoms).

Who may not be able to join:

  • People who have another condition that could cause similar symptoms to IBS, such as celiac disease, inflammatory bowel disease, HIV/AIDS, certain tumors, or other conditions that a doctor believes could be confused with IBS (confirm with trial site for the full list).
  • People with poorly controlled diabetes (confirm with trial site for specific blood sugar threshold).
  • People who have had surgery to remove part of their bowel or colon.
  • People with severe depression (based on a standard questionnaire score) or who have thoughts of suicide — these individuals will be referred to their doctor for appropriate support.
  • People who regularly take opioid pain medications (such as morphine or oxycodone), as these can strongly affect the gut.
  • People who have a known seizure disorder.
  • People whose bowel symptoms are believed to be caused by a known pelvic floor problem.
  • People who currently drink alcohol in a way that is considered harmful or abusive.
  • People who cannot participate fully in the study for any reason, including those who do not speak or read English (as the virtual reality program used in the study is only available in English).
  • People who have previously taken a medication called linaclotide and experienced side effects, did not find it helpful, or are currently taking it at any dose.

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 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Brain Lacy, MD, PhD, Mayo Clinic

Phone: 904-953-6970

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
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
31 May 2024
Est. completion
1 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Changes in IBS symptoms

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: 23 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