Irritable Bowel Syndrome Trial, Recruiting NCT06288672 Sponsor: IBS-80, LLC Condition: Irritable Bowel Syndrome
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Irritable Bowel Syndrome Trial, Recruiting

NCT06288672
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:

  • People who have been diagnosed with Irritable Bowel Syndrome (IBS) by a primary care doctor, gut specialist, or allergy specialist
  • People whose IBS symptoms are not well controlled and who meet a standard set of IBS diagnostic guidelines called the Rome IV criteria (confirm with trial site)

Who may not be able to join:

  • People under 18 years of age
  • People who are pregnant
  • People with a severe skin rash
  • People who have used cortisone-based or certain immune-suppressing medications (such as cyclosporine, azathioprine, tacrolimus, or similar drugs) within two weeks before the skin patch testing part of the study, or who plan to use them during the study
  • People who are not able to complete all parts of the 18-week study, including following specific diet instructions and responding to all text or email questionnaires
  • People whose back has been exposed to the sun in the two weeks before skin patch testing
  • People who are unwilling or unable to stop following the low FODMAP diet (a specific elimination diet) starting one week before the study and throughout its duration, if this applies
  • People who are unwilling to shave back hair if needed for the patch testing, if this applies
  • People who have recently started or changed IBS medication within 30 days of joining the study
  • People who do not speak English
  • People who are unable to provide written consent to participate
  • People with a history of certain gut conditions — including coeliac disease, liver cirrhosis, bowel cancer, inflammatory bowel disease, or diverticulitis — that have been active in the past two years
  • People who have had bowel surgery (not including appendix removal or gallbladder removal more than six months ago)
  • People with poorly controlled mental health conditions such as severe depression, severe anxiety, schizophrenia, or dementia
  • People who drink more than one alcoholic drink per day (for women) or more than two per day (for men)
  • People who use illegal substances
  • People who use high-dose opioid pain medications
  • People with a severe allergy to adhesive tape

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
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: Michael B Stierstorfer, MD, North Wales Dermatology, PLLC

Phone: 215-699-1929

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
IBS-80, LLC
Registry
ClinicalTrials.gov
Start date
15 August 2023
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Post-Avoidance Diet Relative IBS Symptom Global Assessment

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