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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02651532
• Date of registration: 07/01/2016
• Prospective Registration: No
• Primary sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
• Public title: Confocal Endomicroscopy Utility (p-CLE) in Irritable Bowel Syndrome
• Scientific title: Confocal Endomicroscopy Utility for Diagnosing Mucosa Micro-inflammation in Patients With Irritable Bowel Syndrome
• Date of first enrolment: January 2016
• Target sample size: 74
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02651532
• Study type: Observational

Countries of recruitment

Ecuador

Contacts

• Name: Carlos A Robles-Medranda, MD
• Affiliation: Ecuadorian Institute of Digestive Diseases

Key inclusion & exclusion criteria

Inclusion Criteria:

- Above 18 years old patients

- Who agree to participate in the study

- Ability to provide written informed consent

- Patients with irritable bowel syndrome according to Roma III classification.

Exclusion Criteria:

- Patients, who were receiving nonsteroidal anti-inflammatory drugs, corticosteroids or
antibiotics in the last 4 weeks.

- Patients with heart disease, kidney, liver or severe metabolic disorder, who cannot
tolerate sedation

- Inflammatory bowel disease

- Bacterial overgrowth

- Gastrointestinal bleeding

- Prior history of any king of colitis (actinic, infectious, ischemic, microscopic
colitis)

- Suspected colonic obstruction or history of previous obstruction

- Prior history of colectomy surgery

- Patients with an ileostomy or a colostomy

- Patients with difficulty understanding instructions of bowel preparation

- Known allergy to fluorescein or shellfish

- Pregnancy and lactation

- Bowel preparation will be evaluated using the Boston Bowel Preparation Scale. (9)
Patients with < 2 points in at least one of the three segments of the colon (rectum
plus left-side colon, transverse colon plus left and right flexure, right-side colon)
will be excluded from statistical analysis as well as those who after the beginning of
the colonoscopy, had to be aborted because of an inability to reach the cecum by
unfavorable anatomy or impassable tumors / stenosis.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome (IBS)

Intervention(s)

Device: Confocal Laser Endomicroscopy

Primary Outcome(s)

Confocal Laser Endomicroscopy (CLE) utility for diagnosing microscopic inflammation of the mucosa in patients with irritable bowel syndrome (IBS) [Time Frame: four month]

Secondary Outcome(s)

Relationship between microscopic inflammation and sex, age and the subtypes of IBS. [Time Frame: four month]

Secondary ID(s)

ENE12016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors