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Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet

Primary Purpose

Non Celiac Gluten Sensitivity

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
gluten
gluten free flour
Sponsored by
Università degli Studi di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non Celiac Gluten Sensitivity focused on measuring Celiac Disease, Gluten Sensitivity, Gluten, Double-blind challenge, placebo-controlled challenge, Gluten free flour

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adherence to gluten free diet without medical need
  • Negative Celiac Disease related serology (while on gluten containing diet)
  • Normal villous structure at duodenal biopsy (while on gluten containing diet)

Exclusion Criteria:

  • Diagnosis of Celiac Disease
  • Diagnosis of Wheat Allergy
  • Diagnosis of organic gastrointestinal disease
  • Severe concomitant disease

Sites / Locations

  • University and Spedali Civili of Brescia, Unit of Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

gluten

gluten free flour

Arm Description

10 grams of gluten in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet

10 grams of gluten free flour in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet

Outcomes

Primary Outcome Measures

Patient's ability to correctly identify the phase with gluten
time 0: start of first challenge (phase A, either with gluten or gluten free flour) time 10: end of phase A and start of wash-out period time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) time 35: end of phase B

Secondary Outcome Measures

Changes in serum level of anti-tissue transglutaminases immunoglobulin A (IgA)/immunoglobulin G (IgG) and of anti-gliadin IgA/IgG
time 0: start of first challenge (phase A, either with gluten or gluten free flour) time 10: end of phase A and start of wash-out period time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) time 35: end of phase B
Change in Fatigue Visual Scale
time 0: start of first challenge (phase A, either with gluten or gluten free flour) time 10: end of phase A and start of wash-out period time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) time 35: end of phase B
Change in Gastrointestinal Rating Score (GSRS) during Challenge with and without gluten
Time 0: Start of first challenge (phase A, either with gluten or gluten free flour) Time 10: end of phase A and start of wash-out period Time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) Time 35: end of phase B At the beginning of Low-FODMAPs diet After two months of Low-FODMAPs diet
Change in symptoms' score (1 to 7 Likert scale) as recorded on a daily diary
time 0: start of first challenge (phase A, either with gluten or gluten free flour) time 10: end of phase A and start of wash-out period time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) time 35: end of phase B

Full Information

First Posted
April 4, 2013
Last Updated
December 5, 2014
Sponsor
Università degli Studi di Brescia
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1. Study Identification

Unique Protocol Identification Number
NCT01827566
Brief Title
Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet
Official Title
Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial With a Cross-over Design to Assess the Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Brescia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the prevalence of Gluten Sensitivity, by a double-blind placebo-controlled challenge with gluten, followed by two months period of Low-FODMAPs (Fermentable Oligosaccharides Disaccharides Monosaccharides And Polyols) diet, in patients spontaneously adherent to gluten free diet because of symptoms upon gluten exposure and in whom diagnosis of Celiac Disease and Wheat Allergy has been ruled out.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Celiac Gluten Sensitivity
Keywords
Celiac Disease, Gluten Sensitivity, Gluten, Double-blind challenge, placebo-controlled challenge, Gluten free flour

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gluten
Arm Type
Active Comparator
Arm Description
10 grams of gluten in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet
Arm Title
gluten free flour
Arm Type
Placebo Comparator
Arm Description
10 grams of gluten free flour in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet
Intervention Type
Other
Intervention Name(s)
gluten
Intervention Type
Other
Intervention Name(s)
gluten free flour
Primary Outcome Measure Information:
Title
Patient's ability to correctly identify the phase with gluten
Description
time 0: start of first challenge (phase A, either with gluten or gluten free flour) time 10: end of phase A and start of wash-out period time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) time 35: end of phase B
Time Frame
Time (days) 35
Secondary Outcome Measure Information:
Title
Changes in serum level of anti-tissue transglutaminases immunoglobulin A (IgA)/immunoglobulin G (IgG) and of anti-gliadin IgA/IgG
Description
time 0: start of first challenge (phase A, either with gluten or gluten free flour) time 10: end of phase A and start of wash-out period time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) time 35: end of phase B
Time Frame
Time (days) 0, 10, 25, 35
Title
Change in Fatigue Visual Scale
Description
time 0: start of first challenge (phase A, either with gluten or gluten free flour) time 10: end of phase A and start of wash-out period time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) time 35: end of phase B
Time Frame
Time (days) 0, 10, 25, 35
Title
Change in Gastrointestinal Rating Score (GSRS) during Challenge with and without gluten
Description
Time 0: Start of first challenge (phase A, either with gluten or gluten free flour) Time 10: end of phase A and start of wash-out period Time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) Time 35: end of phase B At the beginning of Low-FODMAPs diet After two months of Low-FODMAPs diet
Time Frame
Time (days) 0,10, 25, 35
Title
Change in symptoms' score (1 to 7 Likert scale) as recorded on a daily diary
Description
time 0: start of first challenge (phase A, either with gluten or gluten free flour) time 10: end of phase A and start of wash-out period time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour) time 35: end of phase B
Time Frame
From Time 0 (days) to 10 and from 25 to 35

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adherence to gluten free diet without medical need Negative Celiac Disease related serology (while on gluten containing diet) Normal villous structure at duodenal biopsy (while on gluten containing diet) Exclusion Criteria: Diagnosis of Celiac Disease Diagnosis of Wheat Allergy Diagnosis of organic gastrointestinal disease Severe concomitant disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Lanzini, MD, PhD
Organizational Affiliation
University of Brescia, Unit of Gastroenterology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Barbara Zanini, MD, PhD
Organizational Affiliation
University of Brescia, Unit of Gastroenterology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chiara Ricci, MD, PhD
Organizational Affiliation
University of Brescia, Unit of Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University and Spedali Civili of Brescia, Unit of Gastroenterology
City
Brescia
ZIP/Postal Code
I-25123
Country
Italy

12. IPD Sharing Statement

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Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet

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