Celiac DiseaseNCT03731806
Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease
An observational study of Celiac Disease, run by Tazeen Rasheed at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 60 years
- Conditions the study is for
- Celiac Disease
- How many people
- 0 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2019to Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 60 years
- All sexes
- Child, Adult
Study population: Patients of celiac disease presenting to the OPD or admitted in Medical wards of Dr.Ruth KM Pfau ,Civil Hospital Karachi, Pakistan.
Who may be able to join
- All newly diagnosed patients of celiac disease between the ages of 8 \& 60 years.
- Patients who are currently not on gluten free diet.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extent of Small Bowel Involvement on Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease
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.
Read the 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.
- Conditions
- Celiac Disease
- Keywords
- celiac disease, capsule endoscopy
- Medical subject headings
- Celiac Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study startApr 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: funding for capsule could not be secured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tazeen Rasheed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tazeen Rasheed, Dow University of Health Sciences
- Investigators
- Bader F Zuberi, FCPS, Study chair, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731806
- Sponsor's protocol ID
- CAP-CELIAC
- Status last verified
- Feb 2019
- First submitted
- 25 Oct 2018
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22136777Lujan-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.
PubMed 28216978Bonatto 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.
PubMed 27556094
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extent of Small Bowel Involvement on Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease
- ClinicalTrials.gov ID
- NCT03731806
- Acronym / sponsor ID
- CAP-CELIAC
- Conditions
- Celiac Disease
- Keywords
- celiac disease, capsule endoscopy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: funding for capsule could not be secured
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tazeen RasheedUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients of celiac disease presenting to the OPD or admitted in Medical wards of Dr.Ruth KM Pfau ,Civil Hospital Karachi, Pakistan.
Key inclusion criteria (2 listed)
- All newly diagnosed patients of celiac disease between the ages of 8 \& 60 years.
- Patients who are currently not on gluten free diet.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Grading of Celiac Disease on Capsule Endoscopy using Bonatto Classification
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Background: PubMed 22136777Tennyson 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.
- Background: PubMed 28216978Lujan-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.
- Background: PubMed 27556094Bonatto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bader F Zuberi, FCPS study chair
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Tazeen Rasheed at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grading of Celiac Disease on Capsule Endoscopy using Bonatto Classification (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03731806, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.