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

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other)

Overall Status

Completed

CT.gov ID

NCT01864993

Collaborator

(none)

150

Enrollment

Locations

Arms

35.1

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 :

Mar 1, 2013

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain Scores on the Visual Analogue Scales [28 days]
Symptomatic resolution after the instauration of a gluten free diet will be verified by means of VAS scales

Secondary Outcome Measures

Quality of Life [28 days]
patients with non celiac gluten sensitivity will be evaluated by means of SF36 questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Di Busto Arsizio	Busto Arsizio	Lombardia	Italy
2	Ospedale Valduce di Como	Como	Lombardia	Italy
3	Ospedale Maggiore di Crema	Crema		Italy	26013
4	Ospedale S. Maria	Feltre		Italy	32032
5	Arcispedale S. Maria Nuova	Reggio Emilia		Italy	42122