Assessment of Adherence to Gluten Free Diet in Children and Adolescents by Detection of Gluten in Faecal Samples.

Study Purpose

To assess the adherence to gluten free diet by measuring faecal and urinary gluten immunogenic peptides (GIP). This will provide an objective measure for adherence.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
Unknown

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.

Study Type
Observational
Eligible Ages 2 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age 2-17 years.
  • - Either diagnosis of celiac disease or, in controls, no systemic disease or inflammation - For all groups parents will provide informed consent.

Exclusion Criteria:

° Children with suspected or known inflammatory bowel disease or other gastrointestinal or systemic diseases.

Trial Details

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.

Trial ID:
NCT03663309

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.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Rabin Medical Center

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Liron Mondshine, B.Sc
Principal Investigator Affiliation Rabin Medical Center

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Not yet recruiting
Countries

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Celiac Disease in Children
Additional Details

The adherence to the GFD can be assessed through a dietary interview performed by a registered dietitian or patient self-reports, mucosal healing, assessed by a small bowel biopsy or CD serological screening tests showing decreasing levels of antibodies. However, none of these methods offer an accurate measure of dietary compliance. A novel method to monitor the adherence to the GFD by detection of immune-dominant gluten peptides in human faeces or urine using the anti-α -gliadin G12 antibody was described recently in the literature. Gluten peptides, in particular peptides equivalent to the immunogenic

  • - α −gliadin-33-mer peptide, are resistant to gastrointestinal digestion and that ensures a significant amount of the ingested gluten is excreted in faeces.
Consequently, recovery of detectable amounts of the immunogenic fraction in faeces or urine indicates that gluten has passed through the digestive tract, and in the case of urine was absorbed, and, therefore, that gluten has been consumed .

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Raanan Shamir, Prof.

+972-3-9253672

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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