Gluten Sensitivity in Non-Celiac Patients

NCT01485341 | Completed Phase 3 DMC

• 1 other identifier: 61-2-9-2011
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 7

Brief Summary

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.

Conditions

Gluten Sensitivity

Keywords

gluten sensitivity

Outcome Measures

Primary Outcomes (1)

• Symptoms evaluation according to 3 scales: score after 2 weeks of gluten ingestion

  The evaluation will be made according to the score calculated on the basis of three evaluation scales: "Gastrointestinal Symptom Rating Scale "(GSRS), modified, provides a score ranging MIN=15/MAX=60; Extra-gastrointestinal symptoms evaluation scale, proposed on the basis of the symptoms most frequently observed in GS patients, provides a score ranging MIN=9/MAX=34; VQV scale proposed to evaluate the quality of life, provides a score ranging MIN=16/MAX=64. Total score can be no less than 37 (MIN) and not more than 146 (MAX), with a cut-off of 55.

  Change from baseline at 2 weeks

Secondary Outcomes (2)

• Bio-Markers to differentiate GS and CD

  Change from baseline at 2 weeks

• Symptoms evaluation according to 3 scales: scores 2 weeks after completion of intervention

  Return to baseline values at 4 weeks

Study Arms (2)

gluten

ACTIVE COMPARATOR

gluten is administered blindly versus placebo for 15 days at 10 g/day

Dietary Supplement: gluten

rice starch

PLACEBO COMPARATOR

placebo (rice starch) will be administered blindly versus gluten for 15 days at 10 g/day

Dietary Supplement: rice starch

Interventions

gluten DIETARY_SUPPLEMENT

gluten is administered once a day at 10g/day for 15 days

gluten

rice starch DIETARY_SUPPLEMENT

rice starch is administered once a day at 10 g/day for 15 days

rice starch

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (7)

Center for Celiac Research & Treatment, Yawkey Center for Outpatients Care

Boston, Massachusetts, 02114, United States

Location

Università Politecnica delle Marche

Ancona, Italy

Location

Gastroenterologia ed Endoscopia digestiva, Ospedale San Giuseppe Moscati

Avellino, Italy

Location

Gastroenterology, Second University of Naples

Naples, 80138, Italy

Location

Internal Medicine, Policlinico di Palermo

Palermo, Italy

Location

Gastroenterology, University of Salerno

Salerno, Italy

Location

Ospedale "Casa Sollievo della Sofferenza" - IRCCS -

San Giovanni Rotondo (Foggia), Italy

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

Glutens; substandard starch grain6 protein, rice

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins

Study Officials

• Anna Sapone, MD, PhD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher, PhD

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: December 5, 2011
• Study Start: June 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 13, 2016

Record last verified: 2016-04

Locations

US (1); IT (6)