Clinical Trials Directory

Trials / Completed

CompletedNCT03771443

Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease

Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease (Before and After Pilot Study)

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
6 Years – 15 Years
Healthy volunteers
Not accepted

Summary

Celiac disease (CD) is the most common genetically based food intolerance in the world, with a prevalence among approximately 1% of the general population (Guandalini \& Assiri, 2014). CD is a frequent disorder among Egyptian children, both in the general population and in at-risk groups(Abu-Zekry et al., 2008). It is estimated that the incidence of CD is 3 to13 cases per1000, with a higher prevalence among first-degree relatives of patients with CD.Lifelong adherence to a strict gluten free diet (GFD) remains the only available treatment for patients with CD and typically results in a complete return to health. Nevertheless, gluten is not found only in diet, Gluten is commonly used as a binder in products like medication, cosmetics, oral and skin care, and even children's toys. Gluten is found also in toothpastes and other oral health products and it can be swallowed by mistake and initiate immune response(Anon, n.d.). Unfortunately, there is no gluten free toothpaste available in the Egyptian market and it is very expensive if we bought it from Europe or USA. The tube will cost nearly 10 dolars .As a result, the production and availability of gluten free toothpaste in Egypt has become mandatory.

Detailed description

production of an experimental gluten free toothpaste and providing it for children with celiac disease

Conditions

Interventions

TypeNameDescription
DRUGexperimental gluten free toothpastewe prepared gluten free toothpaste in the faculty of pharmacy -Cairo university because there is no gluten free toothpaste available in the Egyptian market .

Timeline

Start date
2019-07-21
Primary completion
2020-01-21
Completion
2020-01-21
First posted
2018-12-11
Last updated
2020-07-21

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03771443. Inclusion in this directory is not an endorsement.