NCT02431585

Brief Summary

Recently a new clinical entity, gluten sensitivity (GS), a form of gluten intolerance in which neither allergic nor autoimmune mechanisms can be identified, has been added to the spectrum of gluten-related disorders. This condition is characterized by gastrointestinal and extra-intestinal symptoms including abdominal pain (68%); eczema or rash (40%); headache (35%); diarrhoea (33%) and fatigue (33%). The small intestine of GS patient is usually normal. The prevalence of GS is not yet established although it is estimated that up to 6% of the general population might be affected. GS has been described only in adults and no data are available for the paediatric population.The main problem with this new condition is that, at present, there are no specific biomarkers to confirm GS diagnosis. In the absence of a serological or histological marker, the diagnosis remains clinical. In order to avoid placebo effect of the dietary treatment, presently GS diagnosis needs to performed with double-blind randomized placebo-controlled challenge provided that both wheat allergy and CD have previously been excluded. The primary aim of the study is to evaluate the prevalence of GS in IBS paediatric patients. The secondary aims are: 1) to describe clinical, serologic, genetic and histological profile of GS patient and 2) to study the role of gluten or other possible wheat components in the onset of GS. Study design Randomized double blind placebo controlled cross over re-challenge trial. Patient consecutively diagnosed as having IBS (Rome III criteria) in whom the diagnosis of coeliac disease and wheat allergy has been excluded, will be considered eligible for the study. Diagnosis of coeliac disease and wheat allergy will be excluded by the negativity of TTG-IgA and/or EMA and of Skin Prick Test, RAST immuno-CAP and Atopy patch test respectively. Patients will entered a three-phase study with a running in phase (phase I: weeks 1-2), diagnostic elimination diet phase (phase II: week 3-4) and re-challenge phase (phase III: week 5-12)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 1, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

October 17, 2014

Last Update Submit

April 30, 2015

Conditions

Irritable Bowel SyndromeGluten Sensitivity

Keywords

abdominal paingluten free dietfunctional gastrointestinal disorders

Outcome Measures

Primary Outcomes (4)

  • The standardized questionnaire (IBS-SS)

    The severity of IBS symptoms

    12 weeks

  • Visual Analog Scale (VAS)

    12 weeks

  • Quality of life Questionnaire

    12 weeks

  • The Faces Pain Scale (FPS)

    12 weeks

Study Arms (1)

rechallenge

OTHER

Double blind placebo controlled cross over

Dietary Supplement: glutenDietary Supplement: placebo

Interventions

glutenDIETARY_SUPPLEMENT
rechallenge
placeboDIETARY_SUPPLEMENT
rechallenge

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 4-18 years;
  • IBS diagnosis according to Roma III criteria;
  • Written informed consent.

You may not qualify if:

  • Coeliac disease;
  • Wheat allergy;
  • Others food allergy;
  • Type 1 Diabetes;
  • Others Chronic and or Malignant diseases;
  • H. Pylori infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Department "B Trambusti" Ospedale Giovanni XXIII Via Amendola 270

Bari, Ba, 70126, Italy

RECRUITING

Related Publications (6)

  • Biesiekierski JR, Peters SL, Newnham ED, Rosella O, Muir JG, Gibson PR. No effects of gluten in patients with self-reported non-celiac gluten sensitivity after dietary reduction of fermentable, poorly absorbed, short-chain carbohydrates. Gastroenterology. 2013 Aug;145(2):320-8.e1-3. doi: 10.1053/j.gastro.2013.04.051. Epub 2013 May 4.

    PMID: 23648697BACKGROUND

  • Biesiekierski JR, Newnham ED, Irving PM, Barrett JS, Haines M, Doecke JD, Shepherd SJ, Muir JG, Gibson PR. Gluten causes gastrointestinal symptoms in subjects without celiac disease: a double-blind randomized placebo-controlled trial. Am J Gastroenterol. 2011 Mar;106(3):508-14; quiz 515. doi: 10.1038/ajg.2010.487. Epub 2011 Jan 11.

    PMID: 21224837BACKGROUND

  • Volta U, Bardella MT, Calabro A, Troncone R, Corazza GR; Study Group for Non-Celiac Gluten Sensitivity. An Italian prospective multicenter survey on patients suspected of having non-celiac gluten sensitivity. BMC Med. 2014 May 23;12:85. doi: 10.1186/1741-7015-12-85.

    PMID: 24885375BACKGROUND

  • Catassi C, Bai JC, Bonaz B, Bouma G, Calabro A, Carroccio A, Castillejo G, Ciacci C, Cristofori F, Dolinsek J, Francavilla R, Elli L, Green P, Holtmeier W, Koehler P, Koletzko S, Meinhold C, Sanders D, Schumann M, Schuppan D, Ullrich R, Vecsei A, Volta U, Zevallos V, Sapone A, Fasano A. Non-Celiac Gluten sensitivity: the new frontier of gluten related disorders. Nutrients. 2013 Sep 26;5(10):3839-53. doi: 10.3390/nu5103839.

    PMID: 24077239BACKGROUND

  • Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.

    PMID: 22825366BACKGROUND

  • Francavilla R, Cristofori F, Verzillo L, Gentile A, Castellaneta S, Polloni C, Giorgio V, Verduci E, D'Angelo E, Dellatte S, Indrio F. Randomized Double-Blind Placebo-Controlled Crossover Trial for the Diagnosis of Non-Celiac Gluten Sensitivity in Children. Am J Gastroenterol. 2018 Mar;113(3):421-430. doi: 10.1038/ajg.2017.483. Epub 2018 Jan 30.

    PMID: 29380821DERIVED

MeSH Terms

Conditions

Irritable Bowel SyndromeCeliac DiseaseAbdominal PainGastrointestinal Diseases

Interventions

Glutens

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesDigestive System DiseasesMalabsorption SyndromesMetabolic DiseasesNutritional and Metabolic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

ProlaminsGrain ProteinsPlant ProteinsProteinsAmino Acids, Peptides, and ProteinsSeed Storage Proteins

Central Study Contacts

Ruggiero Francavilla, MD

CONTACT

00395592063rfrancavilla@me.com

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
MD, PHD

Study Record Dates

First Submitted

October 17, 2014

First Posted

May 1, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 1, 2015

Record last verified: 2015-04

Locations

IT(1)