Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||11 Years - 16 Years|
Inclusion Criteria:All participants:
- - Male or Female, aged 11 - 16 years
- Have a medical diagnosis of Coeliac Disease
- Attending Secondary school
- Able to speak fluent English
- Have been under the care of the Paediatric Gastroenterology service at the local
Children's Hospital for >3 months and have had >1 follow-up appointment
For participants aged 11-15 only:
- Willing and able to give assent for participation in the study
- Parent/guardian is willing and able to give informed consent for their child's
participation in the study
For participants aged 16:
• Willing and able to give consent for participation in the study
Exclusion Criteria:- Young people with comorbid gastro-intestinal conditions - Young people currently receiving psychological support from any psychological service.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Oxford|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||University of Oxford|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Celiac Disease in Children, Celiac Disease, Celiac, Disclosure, Stigma, Social, Emotional Problem, Mental Health Wellness 1|
- - Coeliac Disease is a genetic lifelong autoimmune condition whereby ingesting gluten leads to a range of idiosyncratic symptoms including diarrhoea, abdominal pain and chronic fatigue.
- - The recruiting service diagnoses approximately 30 young people with coeliac disease each year and follow-up an additional 75 young people living with the condition.
- - The service is motivated to implement changes that further integrated care by acknowledging the interdependence among one's biological, social and psychological needs, in line with the 10-year plan.
- - Findings could improve young people's experience of the service and access to psychological support.
- - More broadly, this research has the potential to inform NICE guidance around post-diagnosis support for young people with this condition.
- - 16 years and attending secondary school, with a diagnosis of coeliac disease.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.