Phase 2 Irritable Bowel Syndrome Trial, Recruiting NCT06211062 Sponsor: Nova Southeastern University Condition: Irritable Bowel Syndrome
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Phase 2 Irritable Bowel Syndrome Trial, Recruiting

NCT06211062
Recruiting Phase 2

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 have been diagnosed with ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) according to specific medical guidelines called the IOM criteria (confirm with trial site)
  • You also have Irritable Bowel Syndrome (IBS) — specifically the type where you experience both diarrhea and constipation that alternate, or mainly diarrhea — diagnosed by a doctor using specific criteria called Rome IV
  • You are able to give your informed agreement to take part in the study
  • If you are able to become pregnant, you must use effective birth control during the study and for at least six months after the treatment ends
  • You are willing to complete online questionnaires and attend follow-up appointments

Who may not be able to join:

  • You have taken probiotic supplements in the past eight weeks
  • You have taken antibiotics in the past eight weeks
  • You are currently pregnant or breastfeeding
  • You have certain other gut or serious health conditions, including short bowel syndrome, celiac disease, gallbladder disease, pancreatitis, Crohn's disease, ulcerative colitis, severe heart disease, severe neurological conditions, or liver failure
  • You have had surgery on your digestive system within the six months before joining the study
  • You have a history of a psychiatric disorder, or issues with alcohol or illegal drug use

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 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Nancy Klimas, MD, Nova Southeastern University, Institute for Neuroimmune Medicine

Phone: 9542622855

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
Phase 2
Sponsor
Nova Southeastern University
Registry
ClinicalTrials.gov
Start date
20 December 2022
Est. completion
24 February 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The Incidence of Intervention-Related Adverse Events [Safety]; The Measurement of Biomarker Response to an Intervention in the Blood [Efficacy]; level of CRP (C-reactive protein); The pro-inflammatory cytokines level e.g. IL-1, IL-6, and TNF-α; The Symptom Severity Measurement [Efficacy]

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: 28 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