Who is eligible for clinical trial NCT05178017?

Participants must meet the protocol's inclusion criteria for IBS - Irritable Bowel Syndrome. The stated age range is 18 Years to 75 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05178017 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-05-21

Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS) (NCT05178017)

Effectiveness of the Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)

🔵 Active, Not Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Oxford Biomedical Technologies, Inc.

🩺 Plain-English Summary (8th-Grade Level)

A three month follow-up study to evaluate the effectiveness of a tailored anti-inflammatory eating plan guided by a registered dietitian to treat irritable bowel syndrome.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (7 items).

Location: Oxford Biomedical Technologies, Inc. — Riviera Beach, Florida

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program (DIAGNOSTIC_TEST)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Adult patients with an established diagnosis of IBS-D as determined by Rome III or IV Criteria
Have IBS of at least moderate severity
Must be on a stable dose regimen for at least 1 month prior to enrollment
Willing to follow the LEAP program for 3 months
Able to give informed consent
Willing to complete the study

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Individuals with a history of inflammatory bowel disease, celiac disease, abdominal surgeries, cancer patients under treatment, and kidney failure
BMI of 40 or higher
Pregnancy or planned pregnancy or lactation
Any serious illness that will interfere with the study procedures or results
Enrollment in active clinical trial/ experimental therapy within the last 30 days
Currently on another dietary treatment approach

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Oxford Biomedical Technologies, Inc. — Riviera Beach, Florida

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in IBS - Irritable Bowel Syndrome

Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator — Jacksonville, Florida
Psilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS) — New York, New York
Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease — Redwood City, California
Evaluating the Impact of Including Virtual Dietary Education Within an Electronic Irritable Bowel Syndrome Pathway — Halifax, N.S.

Explore by condition: All IBS - Irritable Bowel Syndrome clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗