Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-30

Study Completion Date

2020-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Enteroscopy for Early Diagnosis of Tumors in Celiac Disease

NCT02325232

Small Intestine Cancer Celiac Disease

UNKNOWN NA

Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy (MA-23)

NCT00555737

Celiac Disease

COMPLETED

Intestinal Transglutaminase Antibodies in Celiac Disease Diagnosis

NCT05810441

Celiac Disease

COMPLETED

Pre-endoscopy Serological Testing for Coeliac Disease; a Novel Approach Using Rapid Antibody Testing

NCT02834429

Celiac Disease

COMPLETED

Celiac Disease Diagnosis in Patients With Weakly Positive Serum Anti-Transglutaminase: Duodenal Anti-Endomysium Assay.

NCT02242123

Celiac Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Celiac Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No