NCT01864993

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

2.9 years

First QC Date

May 19, 2013

Last Update Submit

February 22, 2016

Conditions

Non Celiac Gluten Sensitivity

Keywords

non celiac gluten sensitivityglutenirritable bowel syndromefunctional disorders

Outcome Measures

Primary Outcomes (1)

  • Pain Scores on the Visual Analogue Scales

    Symptomatic resolution after the instauration of a gluten free diet will be verified by means of VAS scales

    28 days

Secondary Outcomes (1)

  • Quality of Life

    28 days

Study Arms (2)

suspected NC gluten sensitive subjects

EXPERIMENTAL

Patients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet

Dietary Supplement: glutenDietary Supplement: Placebo

suspected NC gluten sensitive

EXPERIMENTAL

Patients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet

Dietary Supplement: glutenDietary Supplement: Placebo

Interventions

glutenDIETARY_SUPPLEMENT

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

suspected NC gluten sensitivesuspected NC gluten sensitive subjects
PlaceboDIETARY_SUPPLEMENT

Patients responsive to the diet will be invited to blindly assume gluten or placebo following a double blind with cross over scheme

suspected NC gluten sensitivesuspected NC gluten sensitive subjects

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with gastrointestinal functional disorders (irritable bowel syndrome, functional dyspepsia or unspecified functional gastrointestinal symptoms)

You may not qualify if:

  • Celiac disease
  • Alimentary allergies
  • Inflammatory bowel disease
  • Major abdominal surgery
  • Psychiatric disorders
  • Neoplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Ospedale Maggiore di Crema

Crema, Italy, 26013, Italy

Location

Ospedale S. Maria

Feltre, Italy, 32032, Italy

Location

Ospedale Di Busto Arsizio

Busto Arsizio, Lombardy, Italy

Location

Ospedale Valduce di Como

Como, Lombardy, Italy

Location

Arcispedale S. Maria Nuova

Reggio Emilia, 42122, Italy

Location

Related Publications (1)

  • Scricciolo A, Lombardo V, Elli L, Bascunan KA, Doneda L, Rinaldi F, Pinto D, Araya M, Costantino A, Vecchi M, Roncoroni L. Use of a proline-specific endopeptidase to reintroduce gluten in patients with non-coeliac gluten sensitivity: A randomized trial. Clin Nutr. 2022 Sep;41(9):2025-2030. doi: 10.1016/j.clnu.2022.07.029. Epub 2022 Jul 31.

    PMID: 35973395DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Glutens

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ProlaminsGrain ProteinsPlant ProteinsProteinsAmino Acids, Peptides, and ProteinsSeed Storage Proteins

Study Officials

  • Luca Elli, MD, PhD

    Center for Prevention and Diagnosis of Celiac Disease, Fondazione IRCCS Cà Granda

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 19, 2013

First Posted

May 30, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

IT(5)