NCT03731806

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

August 23, 2021

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

October 25, 2018

Last Update Submit

August 17, 2021

Conditions

Celiac Disease

Keywords

celiac diseasecapsule endoscopy

Outcome Measures

Primary Outcomes (1)

  • Grading of Celiac Disease on Capsule Endoscopy using Bonatto Classification

    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

    8 hours

Eligibility Criteria

Age8 Years - 60 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients of celiac disease presenting to the OPD or admitted in Medical wards of Dr.Ruth KM Pfau ,Civil Hospital Karachi, Pakistan.

You may qualify if:

  • All newly diagnosed patients of celiac disease between the ages of 8 \& 60 years.
  • Patients who are currently not on gluten free diet.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruth KM Pauf Civil Hospital

Karachi, Sindh, 74000, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 22136777BACKGROUND

  • 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.

    PMID: 28216978BACKGROUND

  • 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.

    PMID: 27556094BACKGROUND

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bader F Zuberi, FCPS

    Dow University of Health Sciences

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 25, 2018

First Posted

November 6, 2018

Study Start

April 1, 2019

Primary Completion

March 1, 2020

Study Completion

April 1, 2020

Last Updated

August 23, 2021

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)