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Confocal Endomicroscopy Utility (p-CLE) in Irritable Bowel Syndrome

NCT02651532 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 74

Last updated 2018-11-20

No results posted yet for this study

Summary

Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders. It has prevalence in general population of 5-20% and is more common in women and young adults.

Despite being one of the most frequent reasons for consultation many patients are undiagnosed. There are no reliable biomarkers. The diagnosis is clinical, based on the Rome III criteria. IBS is characterized by chronic or recurrent abdominal pain associated with changes in bowel frequency and consistency, when other etiologies are excluded. The combination of the Rome III criteria with the absence of alarm symptoms have a sensitivity of 65%, specificity of 100%, 100% positive predictive value and negative predictive value of 76%.

Current tests commonly fail to obtain an objective diagnosis, and effective therapies are lacking. There are no specific endoscopic findings that can discriminate IBS patients from healthy patients. Most colonoscopies are performed to rule out other etiologies and in more than 50% of the cases are normal.

Conditions

  • Irritable Bowel Syndrome (IBS)

Interventions

DEVICE

Confocal Laser Endomicroscopy

During colonoscopic withdrawal, the colonic mucosa will be observed with white light and be evaluated on the different segments of the colon with the confocal laser endomicroscopy technology in order to search for microscopic inflammation signs (altered crypt architecture, fluorescein leaks and dilated and prominent branching vessels)

Sponsors & Collaborators

  • Instituto Ecuatoriano de Enfermedades Digestivas

    lead OTHER

Principal Investigators

  • Carlos A Robles-Medranda, MD · Ecuadorian Institute of Digestive Diseases

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Ecuador

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02651532 on ClinicalTrials.gov