NCT04019223

Brief Summary

Celiac disease is the most common genetically related food intolerance, worldwide. It is an immune mediated intolerance to gluten (from wheat, barley, or rye) in genetically susceptible individuals .The disease primarily affects the small intestine, where it progressively leads to flattening of the small intestinal mucosa .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Status
unknown

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

July 10, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 10, 2019

Last Update Submit

July 11, 2019

Conditions

Celiac Disease in Children

Outcome Measures

Primary Outcomes (1)

  • measure of Anti- tissue will be performed to calculate the post-test probability of celiac disease.

    tTG are regarded as qualitative, i.e., positive or negative.Values of tTG between 2 and 7 U/mL will be considered as doubtful positive, and those of 7 U/mL or more as positive. cut-off of ≥7 U/mL will be used in this study.

    within 24 hours

Study Arms (2)

anti-tissue transglutaminase group

serum IgA-tissue transglutaminase antibody (tTG) was analyzed in serum using a quantitative automated ELISA method by means of a commercially available detection kit using recombinant human tTG as antigen recommended cut-off by the manufacturer \> 8 U/mL).

Diagnostic Test: anti-tissue transglutaminase groupDiagnostic Test: biopsy group

biopsy group

upper gastrointestinal endoscopic examination will be done and the jejunal histopathological examinations will be done at the Histopathology Laboratory. The features consistent with CD included: hyperplasia of crypts, atrophy of villous, and increase of intraepithelial lymphocytes.Duodenal samples will be processed using haematoxylin/eosin staining and CD3 immunophenotyping. The number of intra-epithelial lymphocytes (IEL), the architecture of villi, and the inflammatory cell infiltration of the lamina propria will be assessed. Histopathological changes will be classified according to the Marsh-Oberhuber criteria.Lymphocytic enteropathy (Marsh 1 lesion) was defined as 25 or more IEL per 100 epithelial nuclei, and normal villous architecture.

Diagnostic Test: anti-tissue transglutaminase groupDiagnostic Test: biopsy group

Interventions

anti-tissue transglutaminase groupDIAGNOSTIC_TEST

Determination of anti-tissue transglutaminase IgA antibodies serum level.

anti-tissue transglutaminase groupbiopsy group
biopsy groupDIAGNOSTIC_TEST

Intestinal biopsy for histopathology study the jejunal histopathological

anti-tissue transglutaminase groupbiopsy group

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients in this research will be subjected to : Besides meticulous history and thorough clinical examination, all the cases will be subjected to the following investigations : * Complete blood count. * Determination of electrolytes serum levels: Na, K, Mg, Ca and Ph. * Liver function tests. * Determination of anti-tissue transglutaminase IgA antibodies serum level. * Intestinal biopsy for histopathology study the jejunal histopathological * examinations will be done at the Histopathology Laboratory. * The features consistent with CD included: hyperplasia * of crypts, atrophy of villous, and increase of intraepithelial * lymphocytes.

You may qualify if:

  • patients with symptoms suggestive of celiac disease

You may not qualify if:

  • chronic active gastrointestinal disease, i.e., irritable bowel syndrome inflammatory bowel disease .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Richey R, Howdle P, Shaw E, Stokes T; Guideline Development Group. Recognition and assessment of coeliac disease in children and adults: summary of NICE guidance. BMJ. 2009 May 27;338:b1684. doi: 10.1136/bmj.b1684. No abstract available.

    PMID: 19474030BACKGROUND

  • Sansotta N, Amirikian K, Guandalini S, Jericho H. Celiac Disease Symptom Resolution: Effectiveness of the Gluten-free Diet. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):48-52. doi: 10.1097/MPG.0000000000001634.

    PMID: 28514243RESULT

  • Burgin-Wolff A, Mauro B, Faruk H. Intestinal biopsy is not always required to diagnose celiac disease: a retrospective analysis of combined antibody tests. BMC Gastroenterol. 2013 Jan 23;13:19. doi: 10.1186/1471-230X-13-19.

    PMID: 23343249RESULT

  • Fasano A, Berti I, Gerarduzzi T, Not T, Colletti RB, Drago S, Elitsur Y, Green PH, Guandalini S, Hill ID, Pietzak M, Ventura A, Thorpe M, Kryszak D, Fornaroli F, Wasserman SS, Murray JA, Horvath K. Prevalence of celiac disease in at-risk and not-at-risk groups in the United States: a large multicenter study. Arch Intern Med. 2003 Feb 10;163(3):286-92. doi: 10.1001/archinte.163.3.286.

    PMID: 12578508RESULT

  • Godfrey JD, Brantner TL, Brinjikji W, Christensen KN, Brogan DL, Van Dyke CT, Lahr BD, Larson JJ, Rubio-Tapia A, Melton LJ 3rd, Zinsmeister AR, Kyle RA, Murray JA. Morbidity and mortality among older individuals with undiagnosed celiac disease. Gastroenterology. 2010 Sep;139(3):763-9. doi: 10.1053/j.gastro.2010.05.041. Epub 2010 Jun 1.

    PMID: 20685275RESULT

  • Murray JA. Celiac disease in patients with an affected member, type 1 diabetes, iron-deficiency, or osteoporosis? Gastroenterology. 2005 Apr;128(4 Suppl 1):S52-6. doi: 10.1053/j.gastro.2005.02.029.

    PMID: 15825127RESULT

  • Rubio-Tapia A, Hill ID, Kelly CP, Calderwood AH, Murray JA; American College of Gastroenterology. ACG clinical guidelines: diagnosis and management of celiac disease. Am J Gastroenterol. 2013 May;108(5):656-76; quiz 677. doi: 10.1038/ajg.2013.79. Epub 2013 Apr 23.

    PMID: 23609613RESULT

  • Rubio-Tapia A, Ludvigsson JF, Brantner TL, Murray JA, Everhart JE. The prevalence of celiac disease in the United States. Am J Gastroenterol. 2012 Oct;107(10):1538-44; quiz 1537, 1545. doi: 10.1038/ajg.2012.219. Epub 2012 Jul 31.

    PMID: 22850429RESULT

Central Study Contacts

Naglaa Abu faddan, professor

CONTACT

00201111872237Naglaa.ibrahim@med.au.edu.eg

Amir Aboelgheit, Lecturer

CONTACT

00201065742277Amircle76@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 15, 2019

Study Start

October 1, 2019

Primary Completion

September 30, 2020

Study Completion

March 1, 2021

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share