A First-in-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
NCT07063823
Celiac Disease, Digestive System Diseases
Stanford, California, United States
View Trial DetailsNCT Number: NCT01129908
The celiac disease (CD) is a disease with an immune and genetic component that is activated by the presence of gluten, and damages the intestine mucosa and causes malabsorption of food.
In the oral environment the investigators see enamel defects and recurrent ulcers.
Celiac patients have to keep a restrict gluten-free diet, in order to prevent the clinical symptoms of the disease (such as diarrhea, stomach ache and weight loss).
It has been assumed that the patients have less cariogenic diet, and that caries prevalence is not as high as in normal population.
In celiac patients the investigators find enamel defects that are characterized with pits and deep fissures and sometimes the complete loss of enamel. These defects are classified by the grading of the CD related DED's (dental enamel defects) according to Aine. These defects are symmetrical defects in the permanent dentition, in teeth that develops at the same time. The cause is thought to be hypocalcaemia or genetic.
These defects were found in 42.2% of celiac patients in appose to only 5.4% in healthy population.
Recurrent ulcers were found in 41% in the oral cavity of celiac patients, compare to 27% in healthy population.
After changing the diet to a gluten-free diet, an improvement is seen in the presence of these ulcers.
Looking for future studies?
Notify Me3 year–18 year
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hadassah Medical Organization
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07063823
Celiac Disease, Digestive System Diseases
Stanford, California, United States
View Trial DetailsNCT07177287
Adults With Celiac Disease, Celiac Disease
Ankara, Turkey (Türkiye)
View Trial DetailsNCT05094232
Celiac Disease, Digestive System Diseases
Terrassa, Barcelona, Spain
View Trial DetailsNCT06178107
Celiac Disease, Digestive System Diseases
Salerno, Italy
View Trial Details