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Symptomatic Response to Gluten Challenge in Patients With Suspected Non Celiac Gluten Sensitivity (Glutox)

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ClinicalTrials.gov Identifier: NCT01864993
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Luca Elli, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Non Celiac Gluten Sensitivity Dietary Supplement: gluten Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Glutox Trial. Symptomatic Response to Gluten Challenge in Patients With Suspected Non Celiac Gluten Sensitivity: a Double Blind Crossover Controlled Trial
Study Start Date : March 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: suspected NC gluten sensitive subjects
Patients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet
Dietary Supplement: gluten
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

Dietary Supplement: Placebo
Patients responsive to the diet will be invited to blindly assume gluten or placebo following a double blind with cross over scheme

Experimental: suspected NC gluten sensitive
Patients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet
Dietary Supplement: gluten
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

Dietary Supplement: Placebo
Patients responsive to the diet will be invited to blindly assume gluten or placebo following a double blind with cross over scheme




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 28 days ]
    patients with non celiac gluten sensitivity will be evaluated by means of SF36 questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with gastrointestinal functional disorders (irritable bowel syndrome, functional dyspepsia or unspecified functional gastrointestinal symptoms)

Exclusion Criteria:

  • Celiac disease
  • Alimentary allergies
  • Inflammatory bowel disease
  • Major abdominal surgery
  • Psychiatric disorders
  • Neoplasia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864993


Locations
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Italy
Ospedale Di Busto Arsizio
Busto Arsizio, Lombardia, Italy
Ospedale Valduce di Como
Como, Lombardia, Italy
Ospedale Maggiore di Crema
Crema, Italy, 26013
Ospedale S. Maria
Feltre, Italy, 32032
Arcispedale S. Maria Nuova
Reggio Emilia, Italy, 42122
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
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Principal Investigator: Luca Elli, MD, PhD Center for Prevention and Diagnosis of Celiac Disease, Fondazione IRCCS Cà Granda

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Responsible Party: Luca Elli, researcher, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT01864993     History of Changes
Other Study ID Numbers: 1876/2012
1876 ( Other Identifier: Fondazione IRCCS Cà Granda )
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Keywords provided by Luca Elli, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
non celiac gluten sensitivity
gluten
irritable bowel syndrome
functional disorders
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases