NCT01827566

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

April 4, 2013

Last Update Submit

December 5, 2014

Conditions

Non Celiac Gluten Sensitivity

Keywords

Celiac DiseaseGluten SensitivityGlutenDouble-blind challenge, placebo-controlled challengeGluten free flour

Outcome Measures

Primary Outcomes (1)

  • 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

    Time (days) 35

Secondary Outcomes (4)

  • Changes in serum level of anti-tissue transglutaminases immunoglobulin A (IgA)/immunoglobulin G (IgG) and of anti-gliadin IgA/IgG

    Time (days) 0, 10, 25, 35

  • Change in Fatigue Visual Scale

    Time (days) 0, 10, 25, 35

  • Change in Gastrointestinal Rating Score (GSRS) during Challenge with and without gluten

    Time (days) 0,10, 25, 35

  • Change in symptoms' score (1 to 7 Likert scale) as recorded on a daily diary

    From Time 0 (days) to 10 and from 25 to 35

Study Arms (2)

gluten

ACTIVE COMPARATOR

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

Other: gluten

gluten free flour

PLACEBO COMPARATOR

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

Other: gluten free flour

Interventions

glutenOTHER
gluten
gluten free flourOTHER
gluten free flour

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University and Spedali Civili of Brescia, Unit of Gastroenterology

Brescia, I-25123, Italy

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

Glutens

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProlaminsGrain ProteinsPlant ProteinsProteinsAmino Acids, Peptides, and ProteinsSeed Storage Proteins

Study Officials

  • Alberto Lanzini, MD, PhD

    University of Brescia, Unit of Gastroenterology

    STUDY CHAIR

  • Barbara Zanini, MD, PhD

    University of Brescia, Unit of Gastroenterology

    PRINCIPAL INVESTIGATOR

  • Chiara Ricci, MD, PhD

    University of Brescia, Unit of Gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Gastroenterology

Study Record Dates

First Submitted

April 4, 2013

First Posted

April 9, 2013

Study Start

July 1, 2012

Primary Completion

March 1, 2013

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

IT(1)