Non Celiac Gluten SensitivityGlutoxNCT01864993
Symptomatic Response to Gluten Challenge in Patients With Suspected Non Celiac Gluten Sensitivity
A study testing gluten in people with Non Celiac Gluten Sensitivity, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 5 sites in Italy.
Trial summary
Non Celiac Gluten Sensitivity (NCGS) is an emergent syndrome mainly inducing gastrointestinal symptoms. NCGS is suspected to be present in the 6% of the population and thus it represents an important issue in health care. Actually it remains difficult to diagnose and prove due to the lack of established criteria. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Celiac Gluten Sensitivity
- What is being tested?
- gluten
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 5 sitesItaly
- Study dates
- Mar 2013to Feb 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with gastrointestinal functional disorders (irritable bowel syndrome, functional dyspepsia or unspecified functional gastrointestinal symptoms)
Who cannot join
- Celiac disease
- Alimentary allergies
- Inflammatory bowel disease
- Major abdominal surgery
- Psychiatric disorders
- Neoplasia
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Ospedale Di Busto Arsizio
Busto Arsizio, Lombardy
Ospedale Valduce di Como
Como, Lombardy
Ospedale Maggiore di Crema
Crema, Italy, 26013
Ospedale S. Maria
Feltre, Italy, 32032
Arcispedale S. Maria Nuova
Reggio Emilia, 42122
About this study
Official title: Glutox Trial. Symptomatic Response to Gluten Challenge in Patients With Suspected Non Celiac Gluten Sensitivity: a Double Blind Crossover Controlled Trial
Non Celiac Gluten Sensitivity (NCGS) is an emergent syndrome mainly inducing gastrointestinal symptoms. NCGS is suspected to be present in the 6% of the population and thus it represents an important issue in health care. Actually it remains difficult to diagnose and prove due to the lack of established criteria. The investigators intention is to establish a diagnostic flowchart to evaluate the real impact of NCGS in a cohort of patients suffering from functional gastrointestinal symptoms.
Read the detailed description
The proposed study has been designed to be a randomised double-blind multicenter clinical trial with crossover. The Coordinating Center will be the "Centro per la Prevenzione e la Diagnosi della Malattia Celiaca", Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milano. Secondary enrollment centers will be Italian Gastroenterology Units with outpatient services. Enrollment criteria will be diagnosis of irritable bowel syndrome (IBS) or functional dyspepsia. Patients with other functional gastrointestinal disorders will be included in the group "Functional non specific gastrointestinal symptoms".
After they give their written informed consent, patients will undergo the diagnostic work-up recommended in case of suspected irritable bowel symptoms/functional dyspepsia and aimed at the exclusion of CD or allergy to alimentary antigens by means of serological testing (anti transglutaminase antibodies) or skin tests, or other gastrointestinal diseases. Endoscopic, histologic and/or imaging exams together with supplemental blood tests will be prescribed on individual cases and according with the international guidelines.
Enrolled subjects will be asked to fill
- a checklist for the evaluation of the psychological profile (SCL90 questionnaire, with the particular aim of evaluating levels of anxiety, depression and somatisation);
- a questionnaire about the perceived level of physical and mental health (SF36 questionnaire);
- Ten centimeters long visual analogue scales (VAS) on the level of satisfaction with their health status and on the intensity of the single symptoms.
At the end of the present phase patients will start a GFD for the subsequent three weeks.
At the end of the GFD period patients will fill VAS and SF36. Only those patients presenting a 30% increase of the global VAS score ("GFD Responders") will continue the study. Conversely, non responders will be considered "non gluten sensitive" and they will finish the trial.
Responders to the GFD period will entry the randomisation phase and will undergo a double-blind stimulation test with cross over. Patients will be randomised to assume gluten or placebo for 7 days. After the treatment patients will fill VAS and SF36.
A diagnosis of NCGS will be ascertained in case of symptomatic response limited to gluten ingestion.
- Conditions
- Non Celiac Gluten Sensitivity
- Being tested
- gluten, Placebo
- Keywords
- non celiac gluten sensitivity, gluten, irritable bowel syndrome, functional disorders
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glutenDietary supplement
The enrolled patients will be invited to follow a gluten free diet. Patients responsive to the diet will be invited to assume gluten or placebo following a double blind with cross over scheme
PlaceboDietary supplement
Patients responsive to the diet will be invited to blindly assume gluten or placebo following a double blind with cross over scheme
| Study group | Role | What they receive |
|---|---|---|
| suspected NC gluten sensitive subjects | Experimental | Patients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet Receives: Dietary Supplement: gluten; Dietary Supplement: Placebo |
| suspected NC gluten sensitive | Experimental | Patients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet Receives: Dietary Supplement: gluten; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Visual Analogue Scales
Symptomatic resolution after the instauration of a gluten free diet will be verified by means of VAS scales
Measured: 28 days
Secondary outcomes (1)
Quality of Life
patients with non celiac gluten sensitivity will be evaluated by means of SF36 questionnaire
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Celiac Gluten SensitivityStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Elli, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Luca Elli, MD, PhD, Principal investigator, Center for Prevention and Diagnosis of Celiac Disease, Fondazione IRCCS Cà Granda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864993
- Sponsor's protocol ID
- 1876/2012
- Other IDs
- 1876
- Acronym
- Glutox
- Status last verified
- Feb 2016
- First submitted
- 19 May 2013
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scricciolo A, Lombardo V, Elli L, Bascunan KA, Doneda L, Rinaldi F, Pinto D, Araya M, Costantino A, Vecchi M, Roncoroni L. Use of a proline-specific endopeptidase to reintroduce gluten in patients with non-coeliac gluten sensitivity: A randomized trial. Clin Nutr. 2022 Sep;41(9):2025-2030. doi: 10.1016/j.clnu.2022.07.029. Epub 2022 Jul 31.
PubMed 35973395
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutox Trial. Symptomatic Response to Gluten Challenge in Patients With Suspected Non Celiac Gluten Sensitivity: a Double Blind Crossover Controlled Trial
- ClinicalTrials.gov ID
- NCT01864993
- Acronym / sponsor ID
- Glutox / 1876/2012
- Conditions
- Non Celiac Gluten Sensitivity
- Keywords
- non celiac gluten sensitivity, gluten, irritable bowel syndrome, functional disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 May 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.
Non Celiac Gluten Sensitivity (NCGS) is an emergent syndrome mainly inducing gastrointestinal symptoms. NCGS is suspected to be present in the 6% of the population and thus it represents an important issue in health care. Actually it remains difficult to diagnose and prove due to the lack of established criteria. The investigators intention is to establish a diagnostic flowchart to evaluate the real impact of NCGS in a cohort of patients suffering from functional gastrointestinal symptoms.
Detailed description
The proposed study has been designed to be a randomised double-blind multicenter clinical trial with crossover. The Coordinating Center will be the "Centro per la Prevenzione e la Diagnosi della Malattia Celiaca", Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milano. Secondary enrollment centers will be Italian Gastroenterology Units with outpatient services. Enrollment criteria will be diagnosis of irritable bowel syndrome (IBS) or functional dyspepsia. Patients with other functional gastrointestinal disorders will be included in the group "Functional non specific gastrointestinal symptoms".
After they give their written informed consent, patients will undergo the diagnostic work-up recommended in case of suspected irritable bowel symptoms/functional dyspepsia and aimed at the exclusion of CD or allergy to alimentary antigens by means of serological testing (anti transglutaminase antibodies) or skin tests, or other gastrointestinal diseases. Endoscopic, histologic and/or imaging exams together with supplemental blood tests will be prescribed on individual cases and according with the international guidelines.
Enrolled subjects will be asked to fill
- a checklist for the evaluation of the psychological profile (SCL90 questionnaire, with the particular aim of evaluating levels of anxiety, depression and somatisation);
- a questionnaire about the perceived level of physical and mental health (SF36 questionnaire);
- Ten centimeters long visual analogue scales (VAS) on the level of satisfaction with their health status and on the intensity of the single symptoms.
At the end of the present phase patients will start a GFD for the subsequent three weeks.
At the end of the GFD period patients will fill VAS and SF36. Only those patients presenting a 30% increase of the global VAS score ("GFD Responders") will continue the study. Conversely, non responders will be considered "non gluten sensitive" and they will finish the trial.
Responders to the GFD period will entry the randomisation phase and will undergo a double-blind stimulation test with cross over. Patients will be randomised to assume gluten or placebo for 7 days. After the treatment patients will fill VAS and SF36.
A diagnosis of NCGS will be ascertained in case of symptomatic response limited to gluten ingestion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suspected NC gluten sensitive subjects | Experimental | Dietary Supplement: gluten, Dietary Supplement: PlaceboPatients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet |
| suspected NC gluten sensitive | Experimental | Dietary Supplement: gluten, Dietary Supplement: PlaceboPatients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with gastrointestinal functional disorders (irritable bowel syndrome, functional dyspepsia or unspecified functional gastrointestinal symptoms)
Key exclusion criteria (6 listed)
- Celiac disease
- Alimentary allergies
- Inflammatory bowel disease
- Major abdominal surgery
- Psychiatric disorders
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 |
|---|---|---|
| glutenThe enrolled patients will be invited to follow a gluten free diet. Patients responsive to the diet will be invited to assume gluten or placebo following a double blind with cross over scheme | Dietary supplement | suspected NC gluten sensitive, suspected NC gluten sensitive subjects |
| PlaceboPatients responsive to the diet will be invited to blindly assume gluten or placebo following a double blind with cross over scheme | Dietary supplement | suspected NC gluten sensitive, suspected NC gluten sensitive subjects |
Primary outcome
Pain Scores on the Visual Analogue Scales
Time frame: 28 days
Symptomatic resolution after the instauration of a gluten free diet will be verified by means of VAS scales
1 secondary outcome
Quality of Life
Time frame: 28 days
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 24 Feb 2016.
- Derived from this study: PubMed 35973395Scricciolo A, Lombardo V, Elli L, Bascunan KA, Doneda L, Rinaldi F, Pinto D, Araya M, Costantino A, Vecchi M, Roncoroni L. Use of a proline-specific endopeptidase to reintroduce gluten in patients with non-coeliac gluten sensitivity: A randomized trial. Clin Nutr. 2022 Sep;41(9):2025-2030. doi: 10.1016/j.clnu.2022.07.029. Epub 2022 Jul 31.
Related trials for Non Celiac Gluten Sensitivity
Recruiting
Urinary Gluten Immunogenic Peptides Detection in Non-celiac Gluten/Wheat Sensitivity
Non-celiac Gluten/Wheat Sensitivity
Recruiting
Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity
Non-celiac Gluten Sensitivity
Not yet recruiting
Inflammatory Back Pain and Gluten Free Diet
Inflammatory Back Pain
RecruitingObservational study
Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks
Familial Mediterranean Fever, Non-celiac Gluten Sensitivity
Recruiting
Bio-markers of Not-celiac Wheat Sensitivity
Not-celiac Wheat Sensitivity
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.
Luca Elli, MD, PhD principal investigator
Center for Prevention and Diagnosis of Celiac Disease, Fondazione IRCCS Cà Granda
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gluten in people with Non Celiac Gluten Sensitivity, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 5 sites 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 1 inclusion and 6 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 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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?
Pain Scores on the Visual Analogue Scales (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01864993, which also lists 1 linked publication.
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 24 Feb 2016.