Celiac DiseaseGluCEDNCT02711696
Randomized Clincal Trial on the Effect of a Restricted Gluten Contamination Elimination Diet Among Celiacs [GluCED]
A study testing GCED, Gluten Contamination Elimination Diet in people with Celiac Disease, run by Università degli Studi di Brescia.
Trial summary
The study assessed whether compete healing of duodenal mucosa in celiac patients with persistent Marsh I-II lesion after 1 year of gluten free diet (GFD): could be achieved by adoption of a diet based exclusively on naturally gluten free products, with the elimination of commercially available processed food (GCED… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- GCED, Gluten Contamination Elimination Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jan 2016
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Marsh I-II lesion at 12-18 months after starting GFD
- Negative Celiac Disease serology
- Strict adherence to gluten free diet without digression
Who cannot join
- presence of Gastrointestinal Symtoms
- presence of Helicobacter pylori infection
About this study
Official title: Randomized Clincal Trial on the Effect of a Restricted Gluten Contamination Elimination Diet in Achieving Complete Mucosal Healing Among Celiac Patients With Persisting Minimal Duodenal Lesions During Gluten Free Diet [GluCED]
The study assessed whether compete healing of duodenal mucosa in celiac patients with persistent Marsh I-II lesion after 1 year of gluten free diet (GFD):
- could be achieved by adoption of a diet based exclusively on naturally gluten free products, with the elimination of commercially available processed food (GCED, Gluten Contamination Elimination Diet);
- may depend upon time of exposure to GFD.
Investigators studied two cohorts of celiac patients, both on GFD, for at least one year:
- cohort A: patients re-biopsied after three months on GCED;
- cohort B: patients re-biopsied after a minimum of further two years on standard GFD.
Read the detailed description
Despite strict adherence to gluten free diet (GFD), the complete healing of the duodenal mucosa of celiac patients is rarely achieved. The cause of the persistence of the inflammation is not yet understood.
It is well known that there is a high degree of variability in individual response to gluten with some patients worsening of duodenal histology upon exposure to very small amount of gluten.
This observation suggest that contamination with gluten of commercially available processed food and/or small amount of gluten in processed foods labeled "gluten-free" (less than 20 ppm) may prevent complete mucosal healing.
This explanation is indirectly supported by a study of Hollon et al. (2013) showing that persistence of gastrointestinal symptoms in celiac patients on a GFD is abolished, in 85% of cases, by the adoption of a diet based exclusively on naturally gluten-free products, and on the elimination from the diet of commercially available processed food and products labeled "gluten free " (Gluten Contamination Elimination Diet, GCED).
The main aim of this study was to assess whether the complete healing of duodenal mucosa in patients with persistent Mars I-II lesions after 1 year on GFD i) could be achieved, as a proof of the concept, by the adoption of a GCED OR ii) may depend upon time of exposure to GFD. To achieve this aim investigators studied 2 cohorts of patients with Marsh I-II lesion after 1 year on GFD: cohort A re-byopsied after 3 month GCED , and cohort B re-biopsied after a minimum of further 2 years on standard GFD.
- Conditions
- Celiac Disease
- Being tested
- GCED, Gluten Contamination Elimination Diet
- Keywords
- Celiac Disease,, Gluten Free Diet, Gluten contamination
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCED, Gluten Contamination Elimination DietBehavioural
A Gluten Free diet based exclusively on naturally gluten-free products and foods, with the elimination from the diet of all commercially available processed food and products labeled "gluten free " (Gluten Contamination Elimination Diet, GCED).
| Study group | Role | What they receive |
|---|---|---|
| A, GCED cohort | Active comparator | GCED, Gluten Contamination Elimination Diet Receives: Behavioral: GCED, Gluten Contamination Elimination Diet |
| B, time cohort | No intervention | Cohort B consisted of patients on long term follow-up that accepted a repeated biopsies 60 or more months later the first control biopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic classification
Assessment of Marsh class (0-I-II-III) on duodenal biopsies in participants from both cohorts
Measured: three months in cohort A, at least sixty months in cohort B
Secondary outcomes (3)
Celiac disease serology
IgA t-TG (class A Antibodies anti tissue Transglutaminases) were measured in particiapnts serum at the same time of dudenal biopsy [Eu t-Tg Eurospital, Trieste, Italy]
Measured: three months in cohort A, at least sixty months in cohort B
TCR+ T cells count
TCR+ T cells were identified using a commercially available method suitable for formalin fixed paraffin embedded dudenal biopsies. A mean of the count of TCR+T cells was obtained with a cut-off value of 4 out of 100 epithelial cells.
Measured: three months in cohort A, sixty months in cohort B
Eosinophils count
Eosinophils were identified and counted on duodenal biopsies with a cut off value of 2 out of 100 epithelial cells.
Measured: three months in cohort A, sixty months in cohort B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionJan 2016
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Lanzini, MD PhD, Università degli Studi di Brescia
- Investigators
- barbara zanini, MD, PhD, Study director, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711696
- Sponsor's protocol ID
- CD_GE_2013
- Acronym
- GluCED
- Status last verified
- Oct 2016
- First submitted
- 7 Mar 2016
- Last updated
- 27 Oct 2016
- 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 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clincal Trial on the Effect of a Restricted Gluten Contamination Elimination Diet in Achieving Complete Mucosal Healing Among Celiac Patients With Persisting Minimal Duodenal Lesions During Gluten Free Diet [GluCED]
- ClinicalTrials.gov ID
- NCT02711696
- Acronym / sponsor ID
- GluCED / CD_GE_2013
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease,, Gluten Free Diet, Gluten contamination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 17 Mar 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.
The study assessed whether compete healing of duodenal mucosa in celiac patients with persistent Marsh I-II lesion after 1 year of gluten free diet (GFD):
- could be achieved by adoption of a diet based exclusively on naturally gluten free products, with the elimination of commercially available processed food (GCED, Gluten Contamination Elimination Diet);
- may depend upon time of exposure to GFD.
Investigators studied two cohorts of celiac patients, both on GFD, for at least one year:
- cohort A: patients re-biopsied after three months on GCED;
- cohort B: patients re-biopsied after a minimum of further two years on standard GFD.
Detailed description
Despite strict adherence to gluten free diet (GFD), the complete healing of the duodenal mucosa of celiac patients is rarely achieved. The cause of the persistence of the inflammation is not yet understood.
It is well known that there is a high degree of variability in individual response to gluten with some patients worsening of duodenal histology upon exposure to very small amount of gluten.
This observation suggest that contamination with gluten of commercially available processed food and/or small amount of gluten in processed foods labeled "gluten-free" (less than 20 ppm) may prevent complete mucosal healing.
This explanation is indirectly supported by a study of Hollon et al. (2013) showing that persistence of gastrointestinal symptoms in celiac patients on a GFD is abolished, in 85% of cases, by the adoption of a diet based exclusively on naturally gluten-free products, and on the elimination from the diet of commercially available processed food and products labeled "gluten free " (Gluten Contamination Elimination Diet, GCED).
The main aim of this study was to assess whether the complete healing of duodenal mucosa in patients with persistent Mars I-II lesions after 1 year on GFD i) could be achieved, as a proof of the concept, by the adoption of a GCED OR ii) may depend upon time of exposure to GFD. To achieve this aim investigators studied 2 cohorts of patients with Marsh I-II lesion after 1 year on GFD: cohort A re-byopsied after 3 month GCED , and cohort B re-biopsied after a minimum of further 2 years on standard GFD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, GCED cohort | Active comparator | Behavioral: GCED, Gluten Contamination Elimination DietGCED, Gluten Contamination Elimination Diet |
| B, time cohort | No intervention | –Cohort B consisted of patients on long term follow-up that accepted a repeated biopsies 60 or more months later the first control biopsy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Marsh I-II lesion at 12-18 months after starting GFD
- Negative Celiac Disease serology
- Strict adherence to gluten free diet without digression
Key exclusion criteria (2 listed)
- presence of Gastrointestinal Symtoms
- presence of Helicobacter pylori infection
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 |
|---|---|---|
| GCED, Gluten Contamination Elimination DietA Gluten Free diet based exclusively on naturally gluten-free products and foods, with the elimination from the diet of all commercially available processed food and products labeled "gluten free " (Gluten Contamination Elimination Diet, GCED). | Behavioural | A, GCED cohort |
Primary outcome
Histologic classification
Time frame: three months in cohort A, at least sixty months in cohort B
Assessment of Marsh class (0-I-II-III) on duodenal biopsies in participants from both cohorts
3 secondary outcomes
Celiac disease serology
Time frame: three months in cohort A, at least sixty months in cohort B
TCR+ T cells count
Time frame: three months in cohort A, sixty months in cohort B
Eosinophils count
Time frame: three months in cohort A, sixty months in cohort B
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 27 Oct 2016.
- 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.
barbara zanini, MD, PhD study director
Università degli Studi di Brescia
Questions about this trial
What is this clinical trial studying?
A study testing GCED, Gluten Contamination Elimination Diet in people with Celiac Disease, run by Università degli Studi di Brescia.
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 3 inclusion and 2 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Histologic classification (time frame: three months in cohort A, at least sixty months in cohort B). 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 27 Oct 2016.