Gluten SensitivityPhase 3NCT03771443
Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease
A Phase 3 study testing experimental gluten free toothpaste in people with Gluten Sensitivity, run by Cairo University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Gluten Sensitivity
- What is being tested?
- experimental gluten free toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jul 2019to 21 Jan 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age above 6 yeas.
- Erupting lower 6.
- Can spit the toothpaste.
- Diagnosed as a celiac patient(pathology\&serology)
Who cannot join
- With a history of allergy to any ingredient present in the toothpaste to be used for treatment
- The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
- Children whose parents had no home or mobile phone to enable post-operative contact.
- Parent that will not sign the consent.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Cairo University
Giza, Al Manial, Cairo, Egypt, 11562
About this study
Official title: Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease (Before and After Pilot Study)
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.
Read the detailed description
production of an experimental gluten free toothpaste and providing it for children with celiac disease
- Conditions
- Gluten Sensitivity
- Being tested
- experimental gluten free toothpaste
- Keywords
- Gluten-free toothpaste,celiac disease, GFD, children
- Medical subject headings
- Celiac Disease, Jones syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental gluten free toothpasteDrug
Also called natural toothpaste
we prepared gluten free toothpaste in the faculty of pharmacy -Cairo university because there is no gluten free toothpaste available in the Egyptian market .
| Study group | Role | What they receive |
|---|---|---|
| gluten free toothpaste | Experimental | experimental gluten free toothpaste with natural ingredients prepared for the study to be used 3 times per day for six months Receives: Drug: experimental gluten free toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcerative events
Reporting from the parent (Yes or No)
Measured: Six months
Secondary outcomes (1)
Inflammation or ulceration
visual (Yes or No)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start21 Jul 2019
- Primary completion21 Jan 2020
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gluten SensitivityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Adel Abd Elhameed, Cairo University
- Investigators
- Eman A Abdelhameed, BSc, Principal investigator, Resident at Pediatric Dentistry and Dental Public Health DepartmentFatma KI Abdelgawad, PhD, Study chair, Assistant Professor at Pediatric Dentistry and Dental Public Health DepartmentKamal M El Motayam, PhD, Study director, Emeritus Professor at Pediatric Dentistry and Dental Public Health Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771443
- Sponsor's protocol ID
- CEBD-CU-2018-12-01
- Status last verified
- Jul 2020
- First submitted
- 8 Dec 2018
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease (Before and After Pilot Study)
- ClinicalTrials.gov ID
- NCT03771443
- Acronym / sponsor ID
- CEBD-CU-2018-12-01
- Conditions
- Gluten Sensitivity
- Keywords
- Gluten-free toothpaste,celiac disease, GFD, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Jul 2019 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gluten free toothpaste | Experimental | Drug: experimental gluten free toothpasteexperimental gluten free toothpaste with natural ingredients prepared for the study to be used 3 times per day for six months |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age above 6 yeas.
- Erupting lower 6.
- Can spit the toothpaste.
- Diagnosed as a celiac patient(pathology\&serology)
Key exclusion criteria (4 listed)
- With a history of allergy to any ingredient present in the toothpaste to be used for treatment
- The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
- Children whose parents had no home or mobile phone to enable post-operative contact.
- Parent that will not sign the consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental gluten free toothpasteAlso: natural toothpastewe prepared gluten free toothpaste in the faculty of pharmacy -Cairo university because there is no gluten free toothpaste available in the Egyptian market . | Drug | gluten free toothpaste |
Primary outcome
Ulcerative events
Time frame: Six months
Reporting from the parent (Yes or No)
1 secondary outcome
Inflammation or ulceration
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman A Abdelhameed, BSc principal investigator
Resident at Pediatric Dentistry and Dental Public Health Department
Fatma KI Abdelgawad, PhD study chair
Assistant Professor at Pediatric Dentistry and Dental Public Health Department
Kamal M El Motayam, PhD study director
Emeritus Professor at Pediatric Dentistry and Dental Public Health Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing experimental gluten free toothpaste in people with Gluten Sensitivity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcerative events (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.