Gluten Sensitivity in Non-Celiac Patients

Completed · Phase 3

Conditions studied: Gluten Sensitivity

In brief

The idea is to evaluate if the so called "Gluten Sensitivity" is a real clinical entity. Gluten sensitive (GS) persons are defined as those patients, being neither celiac or allergic to weat, who develop symptoms following gluten consumption. This will be achieved by evaluating a global symptom score in GS patients receiving gluten compared to those receiving placebo (primary end point). Symptoms to be evaluated: gastrointestinal (Gastrointestinal Symptom Rating Scale, GSRS); not-gastrointestinal (specifically built evaluation scale); VQV scale, built to evaluate quality of life. Gluten or placebo will be administered daily (10 g) for 15 days; for the 15 days before and 15 after all patients will stay on Gluten Free Diet (GFD). Besides clinical evaluation (each week for 6 weeks), intestinal permeability testing and blood sampling will be requested for the identification of possible markers (serological, gut barrier function, immunological and expression of tight junctions constitutive proteins) that may be of help to differentiate the condition of gluten sensitivity (GS) from that of Celiac Disease (CD)(secondary end point). Inclusion and exclusion criteria for patients enrolling are strictly dependant on the given "Gluten sensitivity" definition. We expect to experience a worsening of gastrointestinal and extra-gastrointestinal symptoms, from hours to days, with an increase in the overall symptom score, above the cut off, in at least 45% of GS subjects enrolled and that have received gluten compared to GS who received placebo.

Key facts

Study ID

NCT01485341

Run by

University of Campania Luigi Vanvitelli

People needed

108

Starts

2011-06-01

Expected to finish

2016-04-01

Last updated by the study team

2016-04-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients with age between 18-65 with signs/symptoms compatible with gluten-triggered disorders
• Patients testing negative for celiac disease either by biopsy Marsh 0-1 or those who are HLA-DQ2 and DQ8 negative, as well as tTG and EMA negative
• Patients that improved on a gluten free diet

You may not qualify if…

• Subjects diagnosed with celiac disease (positive TTG and/or EMA, and histology positive with Marsh II or above);
• Subjects diagnosed with wheat allergy
• Subjects with Type 1 Diabetes (T1D)
• Subjects with Inflammatory Bowel Disease (ulcerative colitis or Crohn's disease)
• Pregnancy
• Subjects with Helicobacter Pylori infection and other gastrointestinal infection

Where it is running

• Center for Celiac Research & Treatment, Yawkey Center for Outpatients Care — Boston, Massachusetts, United States
• Università Politecnica delle Marche — Ancona, Italy
• Gastroenterologia ed Endoscopia digestiva, Ospedale San Giuseppe Moscati — Avellino, Italy
• Gastroenterology, Second University of Naples — Naples, Italy
• Internal Medicine, Policlinico di Palermo — Palermo, Italy
• Gastroenterology, University of Salerno — Salerno, Italy
• Ospedale "Casa Sollievo della Sofferenza" - IRCCS - — San Giovanni Rotondo (Foggia), Italy

Full record on ClinicalTrials.gov

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