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Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease

Sponsor
Tazeen Rasheed (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03731806
Collaborator
(none)
0
Enrollment
1
Location
12
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Celiac Disease is an autoimmune disorder that affects approximately 1% of the world's population 1. The diagnosis of CD requires clinical, histopathological and serological factors 2. Since upper gastrointestinal endoscopy allows only visualization of the small bowel up to the second part of duodenum therefore this study was designed to determine involvement of different segments of small bowel using endoscopic scale by Bonatto MW et al 3 in newly diagnosed patients of celiac disease.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Extent of Small Bowel Involvement on Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease
    Anticipated Study Start Date :
    Apr 1, 2019
    Anticipated Primary Completion Date :
    Mar 1, 2020
    Anticipated Study Completion Date :
    Apr 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Grading of Celiac Disease on Capsule Endoscopy using Bonatto Classification [8 hours]

      Bonatto Endoscopic Classification of Celiac 0 = Normal I = Mostly regular villi, some foci, no mosaic pattern II = Agglutinated but visible villi, mosaic pattern III = Mosaic pattern, absence of villi

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 60 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. All newly diagnosed patients of celiac disease between the ages of 8 & 60 years.

    2. Patients who are currently not on gluten free diet.

    Exclusion Criteria:

    1. Patients having intestinal obstruction, strictures, fistulae, dysphagia will be excluded.

    2. Pregnant females will be excluded.

    3. Patients having cardiac pacemakers or other implanted electromedical devices.

    4. Unable to swallow capsule.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ruth KM Pauf Civil Hospital Karachi Sindh Pakistan 74000

    Sponsors and Collaborators

    • Tazeen Rasheed

    Investigators

    • Study Chair: Bader F Zuberi, FCPS, Dow University of Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Tazeen Rasheed, Assistant professor, Dow University of Health Sciences
    ClinicalTrials.gov Identifier:
    NCT03731806
    Other Study ID Numbers:
    • CAP-CELIAC
    First Posted:
    Nov 6, 2018
    Last Update Posted:
    Aug 23, 2021
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Tazeen Rasheed, Assistant professor, Dow University of Health Sciences
    celiac disease
    capsule endoscopy
    Additional relevant MeSH terms:
    Celiac Disease

    Study Results

    No Results Posted as of Aug 23, 2021