- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03731806
Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease
Extent of Small Bowel Involvement on Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease
Study Overview
Status
Conditions
Detailed Description
This cross sectional observational study will take place in Medical Unit-II Ruth KM Pfau Civil Hospital Karachi, Pakistan. All newly diagnosed patients of celiac disease between the ages of 8 & 60 years and patients who are currently not on gluten free diet will be included.
Patients having intestinal obstruction, strictures, fistulae, dysphagia, pregnant females will be excluded. Patients having cardiac pacemakers or other implanted electromedical devices and those who are unable to swallow the capsule will also be excluded.
All patients meeting inclusion criteria will be included. Informed consent will be taken from ethics committee. Patients will be provided proper brief information of procedure and confidentiality of the patients will be ensured. Patients will be advised to start clear liquid diet for 24 hours before the procedure. They will be advised to drink Movcol powder 10 sachet in 500ml of water within 20 mins, 12 hours before the procedure. They will be kept nil orally for 08 hours before the procedure. Syrup Infacol (simethicone) 15ml diluted in 50 ml of water will be given 30 mins before the procedure. Patients will be asked to swallow the capsule with 200 ml of water. Patients will be allowed to take food 4 after ingestion of capsule. All patients will be provided with capsule retrieval kit from stool. Patients will be explained to pass any stool after ingestion of capsule till it passed in stool or up to 7 days whichever is earlier. Capsule retrieved will be brought back to investigators for data retrieval from capsule. Reporting will be done by person trained to interpret capsule endoscopy. This will include presence of any pathology, its severity, approximate length and segment of small intestine involved and quality of bowel preparation.
Categorical data will be presented as frequency and percentage, e.g., gender, findings of capsule endoscopy like, bowel preparation, mosaic pattern,ulcers, erythema, telangiectasia etc. Quantitative data will be presented as mean with standard deviation, e.g., age. Involvement of different segments of small intestine (duodenum, jejunum and Ileum) will be documented. Categorical data will be compared on gender by Chi-square test and quantitative data will be analyzed by student's t-test. Significance level will be set at ≤0.05.
Study Type
Contacts and Locations
Study Locations
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Sindh
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Karachi, Sindh, Pakistan, 74000
- Ruth KM Pauf Civil Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All newly diagnosed patients of celiac disease between the ages of 8 & 60 years.
- Patients who are currently not on gluten free diet.
Exclusion Criteria:
- Patients having intestinal obstruction, strictures, fistulae, dysphagia will be excluded.
- Pregnant females will be excluded.
- Patients having cardiac pacemakers or other implanted electromedical devices.
- Unable to swallow capsule.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grading of Celiac Disease on Capsule Endoscopy using Bonatto Classification
Time Frame: 8 hours
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Bonatto Endoscopic Classification of Celiac
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8 hours
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Bader F Zuberi, FCPS, Dow University of Health Sciences
Publications and helpful links
General Publications
- Tennyson CA, Green PH. The role of capsule endoscopy in patients with nonresponsive celiac disease. Gastrointest Endosc. 2011 Dec;74(6):1323-4. doi: 10.1016/j.gie.2011.07.021. No abstract available.
- Lujan-Sanchis M, Perez-Cuadrado-Robles E, Garcia-Lledo J, Juanmartinena Fernandez JF, Elli L, Jimenez-Garcia VA, Egea-Valenzuela J, Valle-Munoz J, Carretero-Ribon C, Fernandez-Urien-Sainz I, Lopez-Higueras A, Alonso-Lazaro N, Sanjuan-Acosta M, Sanchez-Ceballos F, Rosa B, Gonzalez-Vazquez S, Branchi F, Ruano-Diaz L, Prieto-de-Frias C, Pons-Beltran V, Borque-Barrera P, Gonzalez-Suarez B, Xavier S, Arguelles-Arias F, Herrerias-Gutierrez JM, Perez-Cuadrado-Martinez E, Sempere-Garcia-Arguelles J. Role of capsule endoscopy in suspected celiac disease: A European multi-centre study. World J Gastroenterol. 2017 Jan 28;23(4):703-711. doi: 10.3748/wjg.v23.i4.703.
- Bonatto MW, Kotze L, Orlandoski M, Tsuchyia R, de Carvalho CA, Lima D, Kurachi G, Orso IR, Kotze L. Endoscopic evaluation of celiac disease severity and its correlation with histopathological aspects of the duodenal mucosa. Endosc Int Open. 2016 Jul;4(7):E767-77. doi: 10.1055/s-0042-108190. Epub 2016 Jun 29.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAP-CELIAC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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