Non Celiac Gluten SensitivityNCT01827566
Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet
A study testing gluten and gluten free flour in people with Non Celiac Gluten Sensitivity, run by Università degli Studi di Brescia at 1 site in Italy.
Trial summary
The purpose of this study is to assess the prevalence of Gluten Sensitivity, by a double-blind placebo-controlled challenge with gluten, followed by two months period of Low-FODMAPs (Fermentable Oligosaccharides Disaccharides Monosaccharides And Polyols) diet, in patients spontaneously adherent to gluten free diet… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non Celiac Gluten Sensitivity
- What is being tested?
- gluten and gluten free flour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2012to Mar 2013
- 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
- Adherence to gluten free diet without medical need
- Negative Celiac Disease related serology (while on gluten containing diet)
- Normal villous structure at duodenal biopsy (while on gluten containing diet)
Who cannot join
- Diagnosis of Celiac Disease
- Diagnosis of Wheat Allergy
- Diagnosis of organic gastrointestinal disease
- Severe concomitant disease
Trial locations and contacts
1 site in 1 country.
Italy1 site
University and Spedali Civili of Brescia, Unit of Gastroenterology
Brescia, I-25123
About this study
Official title: Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial With a Cross-over Design to Assess the Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet
The purpose of this study is to assess the prevalence of Gluten Sensitivity, by a double-blind placebo-controlled challenge with gluten, followed by two months period of Low-FODMAPs (Fermentable Oligosaccharides Disaccharides Monosaccharides And Polyols) diet, in patients spontaneously adherent to gluten free diet because of symptoms upon gluten exposure and in whom diagnosis of Celiac Disease and Wheat Allergy has been ruled out.
- Conditions
- Non Celiac Gluten Sensitivity
- Being tested
- gluten, gluten free flour
- Keywords
- Celiac Disease, Gluten Sensitivity, Gluten, Double-blind challenge, placebo-controlled challenge, Gluten free flour
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glutenOther
gluten free flourOther
| Study group | Role | What they receive |
|---|---|---|
| gluten | Active comparator | 10 grams of gluten in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet Receives: Other: gluten |
| gluten free flour | Placebo comparator | 10 grams of gluten free flour in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet Receives: Other: gluten free flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's ability to correctly identify the phase with gluten
- time 0: start of first challenge (phase A, either with gluten or gluten free flour)
- time 10: end of phase A and start of wash-out period
- time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour)
- time 35: end of phase B
Measured: Time (days) 35
Secondary outcomes (4)
Changes in serum level of anti-tissue transglutaminases immunoglobulin A (IgA)/immunoglobulin G (IgG) and of anti-gliadin IgA/IgG
- time 0: start of first challenge (phase A, either with gluten or gluten free flour)
- time 10: end of phase A and start of wash-out period
- time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour)
- time 35: end of phase B
Measured: Time (days) 0, 10, 25, 35
Change in Fatigue Visual Scale
- time 0: start of first challenge (phase A, either with gluten or gluten free flour)
- time 10: end of phase A and start of wash-out period
- time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour)
- time 35: end of phase B
Measured: Time (days) 0, 10, 25, 35
Change in Gastrointestinal Rating Score (GSRS) during Challenge with and without gluten
- Time 0: Start of first challenge (phase A, either with gluten or gluten free flour)
- Time 10: end of phase A and start of wash-out period
- Time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour)
- Time 35: end of phase B
- At the beginning of Low-FODMAPs diet
- After two months of Low-FODMAPs diet
Measured: Time (days) 0,10, 25, 35
Change in symptoms' score (1 to 7 Likert scale) as recorded on a daily diary
- time 0: start of first challenge (phase A, either with gluten or gluten free flour)
- time 10: end of phase A and start of wash-out period
- time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour)
- time 35: end of phase B
Measured: From Time 0 (days) to 10 and from 25 to 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startJul 2012
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Celiac Gluten SensitivityStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 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
- Alberto Lanzini, MD, PhD, Study chair, University of Brescia, Unit of GastroenterologyBarbara Zanini, MD, PhD, Principal investigator, University of Brescia, Unit of GastroenterologyChiara Ricci, MD, PhD, Principal investigator, University of Brescia, Unit of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827566
- Sponsor's protocol ID
- GE-2012-GS
- Status last verified
- Dec 2014
- First submitted
- 4 Apr 2013
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial With a Cross-over Design to Assess the Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet
- ClinicalTrials.gov ID
- NCT01827566
- Acronym / sponsor ID
- GE-2012-GS
- Conditions
- Non Celiac Gluten Sensitivity
- Keywords
- Celiac Disease, Gluten Sensitivity, Gluten, Double-blind challenge, placebo-controlled challenge, Gluten free flour
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2013 (actual)
- First posted
- 9 Apr 2013 (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 purpose of this study is to assess the prevalence of Gluten Sensitivity, by a double-blind placebo-controlled challenge with gluten, followed by two months period of Low-FODMAPs (Fermentable Oligosaccharides Disaccharides Monosaccharides And Polyols) diet, in patients spontaneously adherent to gluten free diet because of symptoms upon gluten exposure and in whom diagnosis of Celiac Disease and Wheat Allergy has been ruled out.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gluten | Active comparator | Other: gluten10 grams of gluten in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet |
| gluten free flour | Placebo comparator | Other: gluten free flour10 grams of gluten free flour in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adherence to gluten free diet without medical need
- Negative Celiac Disease related serology (while on gluten containing diet)
- Normal villous structure at duodenal biopsy (while on gluten containing diet)
Key exclusion criteria (4 listed)
- Diagnosis of Celiac Disease
- Diagnosis of Wheat Allergy
- Diagnosis of organic gastrointestinal disease
- Severe concomitant disease
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 |
|---|---|---|
| gluten | Other | gluten |
| gluten free flour | Other | gluten free flour |
Primary outcome
Patient's ability to correctly identify the phase with gluten
Time frame: Time (days) 35
* time 0: start of first challenge (phase A, either with gluten or gluten free flour) * time 10: end of phase A and start of wash-out period * time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) * time 35: end of phase B
4 secondary outcomes
Changes in serum level of anti-tissue transglutaminases immunoglobulin A (IgA)/immunoglobulin G (IgG) and of anti-gliadin IgA/IgG
Time frame: Time (days) 0, 10, 25, 35
Change in Fatigue Visual Scale
Time frame: Time (days) 0, 10, 25, 35
Change in Gastrointestinal Rating Score (GSRS) during Challenge with and without gluten
Time frame: Time (days) 0,10, 25, 35
Change in symptoms' score (1 to 7 Likert scale) as recorded on a daily diary
Time frame: From Time 0 (days) to 10 and from 25 to 35
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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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.
Alberto Lanzini, MD, PhD study chair
University of Brescia, Unit of Gastroenterology
Barbara Zanini, MD, PhD principal investigator
University of Brescia, Unit of Gastroenterology
Chiara Ricci, MD, PhD principal investigator
University of Brescia, Unit of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gluten and gluten free flour in people with Non Celiac Gluten Sensitivity, run by Università degli Studi di Brescia at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 8 Dec 2014. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Patient's ability to correctly identify the phase with gluten (time frame: Time (days) 35). 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 8 Dec 2014.