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Why IBS Clinical Trials Keep Missing the Right Patients

Efi Kozlovsky
/
February 23, 2026

Irritable bowel syndrome presents a persistent recruitment challenge in clinical research. 

Symptoms differ widely, diagnosis relies heavily on patient-reported experience, and care unfolds across many settings rather than along a single clinical path. Yet recruitment strategies still follow models built for conditions with clear biomarkers and predictable treatment routes, creating a gap between protocol design and the patients trials hope to reach.

A central problem lies in how IBS populations are identified. Patients cycle through primary care, gastroenterology visits, dietary programs, and self-management long before a study appears on their radar. Recruitment efforts focused on specialty clinics or narrow databases reach only a fraction of this population. 

As a result, many individuals who meet eligibility criteria remain outside traditional referral channels.

Symptom Diversity Complicates Targeting

Constipation-predominant, diarrhea-predominant, mixed, and stress-related symptom patterns push patients into different care settings and influence when they seek help. 

Recruitment approaches that rely only on diagnostic codes or prior treatment history narrow the pool too early. Patients whose lived experience aligns with the condition may be filtered out because their data does not match rigid categories.

More accurate identification depends on symptom behavior rather than diagnosis alone. Signals from real-world data, patient-reported inputs, and engagement patterns offer a clearer view of who experiences IBS day to day. 

Without these inputs, recruitment remains limited to patients already labeled within systems that only partially reflect the condition.

Care Pathways Rarely Follow a Straight Line

IBS management shifts between physician visits, dietary changes, mental health support, and over-the-counter remedies. 

Some patients delay formal treatment, while others cycle through therapies with limited success. Recruitment models centered on specialist clinics encounter patients late in this process, after symptoms and expectations have changed.

Strategies that account for these varied paths can meet patients earlier and more consistently. Outreach aligned with how people seek relief, through lifestyle change, online resources, or non-prescription options, mirrors actual behavior and improves the chance of identifying participants before disengagement occurs.

Messaging Influences Who Responds

Patients frequently report frustration with being misunderstood or dismissed because symptoms are subjective. 

Recruitment materials focused only on clinical endpoints may fail to resonate with people concerned primarily with daily function and unpredictability. 

When engagement language reflects symptom experience while staying aligned with protocol requirements, response improves among the populations trials seek to enroll.

Eligibility Criteria Describe Idealized Patients

Protocols define IBS populations through standardized frameworks that support scientific rigor but rarely mirror real-world presentation. 

Overlapping conditions, intermittent symptoms, and inconsistent treatment use are common. Narrow exclusion rules remove many candidates who resemble the intended population but fall outside operational definitions. 

This contributes to screen failure rates that appear procedural but originate in how eligibility is structured.

Recruitment Works Better When Built Around Behavior Instead of Labels

Patterns of symptom-searching, dietary experimentation, and care avoidance provide stronger signals than diagnosis history alone. 

Systems that integrate these behavioral indicators into identification and engagement generate pools that better match protocol goals.

IBS trials miss the right patients when recruitment assumes uniform symptoms and linear care. The condition itself resists those assumptions. Strategies that reflect how patients describe their symptoms, seek relief, and disengage from care improve alignment between protocol design and how patients actually experience the condition.

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