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

NCT02651532 | Completed DMC

• 1 other identifier: ENE12016
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Confocal Laser Endomicroscopy; inflammation; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Confocal Laser Endomicroscopy (CLE) utility for diagnosing microscopic inflammation of the mucosa in patients with irritable bowel syndrome (IBS)

  Number of patients with IBS and microscopic inflammation determinate by CLE

  four month

Secondary Outcomes (1)

• Relationship between microscopic inflammation and sex, age and the subtypes of IBS.

  four month

Study Arms (2)

IBS + Confocal Laser Endomicroscopy

Outpatients with irritable bowel syndrome according to Roma III classification: recurrent abdominal pain or discomfort, at least 3 days per month, in the last 3 months and symptoms begin at least 6 months before diagnosis, associated with 2 or more of: improvement with defecation, start associated with changes in the bowel frequency, start associated with changes in stool consistency. Absence of alarm symptoms: gastrointestinal bleeding, weight loss, anemia, night-time symptoms, fever, family history of colorectal cancer or celiac disease, elevated erythrocyte sedimentation rate, positive fecal occult blood test.

Device: Confocal Laser Endomicroscopy

Control + Confocal Laser Endomicroscopy

Outpatients without IBS symptoms, undergoing colonoscopy for colorectal cancer screening

Device: Confocal Laser Endomicroscopy

Interventions

Confocal Laser Endomicroscopy DEVICE

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)

Control + Confocal Laser Endomicroscopy; IBS + Confocal Laser Endomicroscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients with irritable bowel syndrome according to Roma III classification: recurrent abdominal pain or discomfort, at least 3 days per month, in the last 3 months and symptoms begin at least 6 months before diagnosis, associated with 2 or more of: 1) Improvement with defecation, 2) Start associated with changes in the bowel frequency, 3) Start associated with changes in stool consistency. In the absence of alarm symptoms. It will be measured in all patients serology for celiac disease, serum thyroid-stimulating hormone (TSH) and parasitological test. It will be done, in high suspicion patients, stool culture, breath test for lactose intolerance and breath test for bacterial overgrowth.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Ecuadorian Institute of Digestive Diseases

Guayaquil, Guayas, 090505, Ecuador

Location

Related Publications (14)

• Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.

  PMID: 16678561 RESULT

• Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.

  PMID: 16678553 RESULT

• Mayer EA. Clinical practice. Irritable bowel syndrome. N Engl J Med. 2008 Apr 17;358(16):1692-9. doi: 10.1056/NEJMcp0801447.

  PMID: 18420501 RESULT

• Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology. 2002 Dec;123(6):2108-31. doi: 10.1053/gast.2002.37095. No abstract available.

  PMID: 12454866 RESULT

• Tornblom H, Lindberg G, Nyberg B, Veress B. Full-thickness biopsy of the jejunum reveals inflammation and enteric neuropathy in irritable bowel syndrome. Gastroenterology. 2002 Dec;123(6):1972-9. doi: 10.1053/gast.2002.37059.

  PMID: 12454854 RESULT

• Kiesslich R, Goetz M, Angus EM, Hu Q, Guan Y, Potten C, Allen T, Neurath MF, Shroyer NF, Montrose MH, Watson AJ. Identification of epithelial gaps in human small and large intestine by confocal endomicroscopy. Gastroenterology. 2007 Dec;133(6):1769-78. doi: 10.1053/j.gastro.2007.09.011. Epub 2007 Sep 16.

  PMID: 18054549 RESULT

• Turcotte JF, Kao D, Mah SJ, Claggett B, Saltzman JR, Fedorak RN, Liu JJ. Breaks in the wall: increased gaps in the intestinal epithelium of irritable bowel syndrome patients identified by confocal laser endomicroscopy (with videos). Gastrointest Endosc. 2013 Apr;77(4):624-30. doi: 10.1016/j.gie.2012.11.006. Epub 2013 Jan 26.

  PMID: 23357497 RESULT

• Fritscher-Ravens A, Schuppan D, Ellrichmann M, Schoch S, Rocken C, Brasch J, Bethge J, Bottner M, Klose J, Milla PJ. Confocal endomicroscopy shows food-associated changes in the intestinal mucosa of patients with irritable bowel syndrome. Gastroenterology. 2014 Nov;147(5):1012-20.e4. doi: 10.1053/j.gastro.2014.07.046. Epub 2014 Jul 30.

  PMID: 25083606 RESULT

• Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.

  PMID: 19136102 RESULT

• Kuiper T, Kiesslich R, Ponsioen C, Fockens P, Dekker E. The learning curve, accuracy, and interobserver agreement of endoscope-based confocal laser endomicroscopy for the differentiation of colorectal lesions. Gastrointest Endosc. 2012 Jun;75(6):1211-7. doi: 10.1016/j.gie.2012.01.040. Epub 2012 Mar 28.

  PMID: 22459661 RESULT

• Wallace M, Lauwers GY, Chen Y, Dekker E, Fockens P, Sharma P, Meining A. Miami classification for probe-based confocal laser endomicroscopy. Endoscopy. 2011 Oct;43(10):882-91. doi: 10.1055/s-0030-1256632. Epub 2011 Aug 4.

  PMID: 21818734 RESULT

• Becker V, von Delius S, Bajbouj M, Karagianni A, Schmid RM, Meining A. Intravenous application of fluorescein for confocal laser scanning microscopy: evaluation of contrast dynamics and image quality with increasing injection-to-imaging time. Gastrointest Endosc. 2008 Aug;68(2):319-23. doi: 10.1016/j.gie.2008.01.033. Epub 2008 Apr 24.

  PMID: 18436217 RESULT

• Kiesslich R, Goetz M, Lammersdorf K, Schneider C, Burg J, Stolte M, Vieth M, Nafe B, Galle PR, Neurath MF. Chromoscopy-guided endomicroscopy increases the diagnostic yield of intraepithelial neoplasia in ulcerative colitis. Gastroenterology. 2007 Mar;132(3):874-82. doi: 10.1053/j.gastro.2007.01.048. Epub 2007 Jan 31.

  PMID: 17383417 RESULT

• Li CQ, Xie XJ, Yu T, Gu XM, Zuo XL, Zhou CJ, Huang WQ, Chen H, Li YQ. Classification of inflammation activity in ulcerative colitis by confocal laser endomicroscopy. Am J Gastroenterol. 2010 Jun;105(6):1391-6. doi: 10.1038/ajg.2009.664. Epub 2009 Nov 24.

  PMID: 19935787 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Histological biopsies of the colonic mucosal

MeSH Terms

Conditions

Irritable Bowel Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos A Robles-Medranda, MD

  Ecuadorian Institute of Digestive Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 11, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

EC (1)