Celiac DiseaseNCT02690532
Gut Permeability Assessment in Celiac and Gluten Sensitive Children
An observational study of Celiac Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
This study will assess the effect of gluten on gut barrier function. Investigators at the Mayo Clinic have developed a new gut permeability test using rhamnose (sugar \& water solution), and are hoping to prove its effectiveness in a clinical setting. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 1 Aug 2018
- Phase
- Observational
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will consist of three groups of children, aged 2-17 years. The first group will be children with siblings that have celiac disease, the second group will be children with non-celiac gluten sensitivity and the third group will be healthy children.
High Risk group:
- Sibling with a confirmed diagnosis of celiac disease
- No history Celiac disease or any other bowel disease
Non-Celiac Gluten Sensitivity group:
- Self-diagnosis of gluten sensitivity
- No history of celiac disease or other bowel disease
Healthy group:
- Absence of celiac disease or any other bowel disease
- No sensitivity to gluten
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Role of Gut Permeability in Developing Celiac Disease and Non-Celiac Gluten Sensitivity
This study will assess the effect of gluten on gut barrier function. Investigators at the Mayo Clinic have developed a new gut permeability test using rhamnose (sugar \& water solution), and are hoping to prove its effectiveness in a clinical setting.
Read the detailed description
The aim of this study is to assess effect of gluten on the gut barrier function in patients at high risk for celiac disease and non-celiac gluten sensitivity (NCGS) patients. This study will assess the gut permeability in three groups of patients 1) children who are at high risk for developing celiac disease (CD) (siblings of patients with celiac disease), 2) Children who are self-diagnosed with NCGS and 3) control group of patients matched for age and gender. Patients will undergo celiac serologic and genetic testing, after which the rhamnose test will be performed to assess the presence of increased gut permeability.
- Conditions
- Celiac Disease
- Keywords
- Celiac, Gluten, Sensitivity, Permeability, Non-celiac gluten intolerance, Gastrointestinal Diseases, Digestive System Diseases
- Medical subject headings
- Celiac Disease, Hypersensitivity, Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High risk group | Children who are at high risk for developing celiac disease (siblings diagnosed with celiac disease). | |
| Non-celiac group | Children who are self-diagnosed with non-celiac gluten sensitivity. | |
| Control Group | Healthy control group (matched for age and gender). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Permeability
Assess the effect of gluten on gut permeability in children at high risk of developing celiac disease or gluten sensitivity
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startMar 2016
- Primary completion1 Jul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imad Absah, Mayo Clinic
- Investigators
- Imad Absah, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690532
- Sponsor's protocol ID
- 15-006018
- Status last verified
- Aug 2018
- First submitted
- 19 Feb 2016
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Gut Permeability in Developing Celiac Disease and Non-Celiac Gluten Sensitivity
- ClinicalTrials.gov ID
- NCT02690532
- Acronym / sponsor ID
- 15-006018
- Conditions
- Celiac Disease
- Keywords
- Celiac, Gluten, Sensitivity, Permeability, Non-celiac gluten intolerance, Gastrointestinal Diseases, Digestive System Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 24 Feb 2016 (estimated)
- 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.
This study will assess the effect of gluten on gut barrier function. Investigators at the Mayo Clinic have developed a new gut permeability test using rhamnose (sugar \& water solution), and are hoping to prove its effectiveness in a clinical setting.
Detailed description
The aim of this study is to assess effect of gluten on the gut barrier function in patients at high risk for celiac disease and non-celiac gluten sensitivity (NCGS) patients. This study will assess the gut permeability in three groups of patients 1) children who are at high risk for developing celiac disease (CD) (siblings of patients with celiac disease), 2) Children who are self-diagnosed with NCGS and 3) control group of patients matched for age and gender. Patients will undergo celiac serologic and genetic testing, after which the rhamnose test will be performed to assess the presence of increased gut permeability.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High risk group | – | –Children who are at high risk for developing celiac disease (siblings diagnosed with celiac disease). |
| Non-celiac group | – | –Children who are self-diagnosed with non-celiac gluten sensitivity. |
| Control Group | – | –Healthy control group (matched for age and gender). |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will consist of three groups of children, aged 2-17 years. The first group will be children with siblings that have celiac disease, the second group will be children with non-celiac gluten sensitivity and the third group will be healthy children.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut Permeability
Time frame: Baseline
Assess the effect of gluten on gut permeability in children at high risk of developing celiac disease or gluten sensitivity
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 15 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Imad Absah, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Aug 2018. 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 United States. 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.
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?
Gut Permeability (time frame: Baseline). 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 15 Aug 2018.