An observational study in Celiac Disease in Children, Pediatric Disorder and Health, Subjective, sponsored by Sahlgrenska University Hospital. Completed at 2 sites in Sweden. Open to participants aged 2 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-09.
Sponsored by Sahlgrenska University Hospital · Observational
The investigators aim to examine the feasibility of incorporating serological celiac disease (CD) screening into general pediatric outpatient clinics in Sweden and through structured monitoring examine the effects of diagnosing and treating screening-detected CD.
Screening will be tailored to general pediatric outpatient clinics in the Gothenburg metropolitan area with the goal to screen 1000 children over four months. Screening for CD will be carried out by measuring tissue transglutaminase autoantibodies (TGA) in blood. Children who are persistently TGA positive will be enrolled into a 6-12-month follow-up protocol responsible for diagnosing CD, installation of gluten-free diet and to assess their short-term impact upon the child's wellbeing. Other components to assess include (I) the feasibility to incorporate CD screening into busy pediatric practices; (II) parental/child interest in, and satisfaction with, participating in a CD screening program and (III) identifying key considerations for a possible scaled-up, broad-based, CD screening.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's enrollment of 496 is above the median of 160 across 126 observational studies indexed under Celiac Disease.
Browse Celiac Disease studies →Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients at pediatric outpatient clinics in Gothenburg metro area
Exclusion Criteria for serological screening:
celiac disease-specific autoantibodies
Number of participants diagnosed with celiac disease
Celiac disease diagnosed according to European pediatric (ESPGHAN) guidelines
Time frame: Assessed after 6-12 months of follow-up
Number of participants identified with celiac disease autoimmunity
Celiac disease autoimmunity defined by having two consecutive positive tests for tissue transglutaminase (TTG) autoantibodies
Time frame: Assessed after performed two tests of TTG (apprx. 1-2 months after enrollment)
Plan to share: No — Individual participant data will not be shared in accordance with the ethical approval of this study
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sahlgrenska University Hospital