Prevalence of Gluten Sensitivity in Irritable Bowel Syndrome: The First Study in Paediatrics. (GS-IBS)

April 30, 2015 updated by: Ruggiero Francavilla, University of Bari

Prevalence of Gluten Sensitivity in Irritable Bowel Syndrome: The First Study in Paediatrics. (GS-IBS)

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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).

The following procedure will be performed at different times (Table 1):

  1. Entry (Time 0): Blood test, HLA on blood spot, collection of urine and stools;

  2. Running-in (phase I: week 1-2): Visual Analogue Scale (VAS) and (IBS-SS); STAIC test; Bristol stool chart (mBSFC), extra-intestinal symptoms questionnaire.

    At the end of week 2 patients still complaining IBS symptoms (IBS-SS>75) will proceed in the trial and undergo endoscopy plus biopsies on voluntary basis.

  3. Diagnostic gluten elimination diet phase (phase II: week 3-4): Visual Analogue Scale (VAS) and (IBS-SS); STAIC test; Bristol stool chart (mBSF-C), extra-intestinal symptoms questionnaire. Collection of urine and stools (end of week 4).

    At the end of week 4 only patients with a significant reduction of IBS symptoms or VAS (greater than 30%) will proceed in the re-challenge phase.

    The challenge phase will be subdivided in Two phases: one double blind phase (product A and B) plus a single blind phase (product C).

  4. Product A (week 5-6): Visual Analogue Scale (VAS) and (IBS-SS), STAIC test; Bristol stool chart (mBSF-C), extra-intestinal symptoms questionnaire, collection of urine and stools (end of week 6);
  5. Product B (week 8-9): Visual Analogue Scale (VAS) and (IBS-SS), STAIC test; Bristol stool chart (mBSF-C), extra-intestinal symptoms questionnaire, collection of urine and stools (end of week 9)
  6. Product C (week 11-12): Visual Analogue Scale (VAS) and (IBS-SS), STAIC test; Bristol stool chart (mBSF-C), extra-intestinal symptoms questionnaire, collection of urine and stools (end of week 12)

Challenge procedure

Double Blind phase (Product A and B):

Children will be asked to keep following the strict gluten free diet and to take a sachet daily for a period of two weeks each interspersed by a washout phase of one week. Sachet will contain either pure gluten (10 grams daily) or gluten free flour (10 grams daily - SHAR). Sachets containing placebo will have the same shape, dimension, indication and appearance as those containing the gluten and will be provided by a bagging factory, which will ensure that the study will be blinded for investigators and patients. Sachets will be named A or B.

Single Blind Challenge (Product C):

To assess whether other components of wheat other gluten are involved in the onset of GS, children will be asked to take for a period of two weeks, while on gluten free diet, a muffin made of wheat flour in a single blind fashion.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Ba
      • Bari, Ba, Italy, 70126
        • Recruiting
        • Pediatric Department "B Trambusti" Ospedale Giovanni XXIII Via Amendola 270
        • Principal Investigator:
          • Ruggiero Francavilla, MD
        • Sub-Investigator:
          • Fernanda Cristofori, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: rechallenge
Double blind placebo controlled cross over
Dietary supplement: placebo
Dietary supplement: gluten

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The standardized questionnaire (IBS-SS)
Time Frame: 12 weeks
The severity of IBS symptoms
12 weeks
Visual Analog Scale (VAS)
Time Frame: 12 weeks
12 weeks
Quality of life Questionnaire
Time Frame: 12 weeks
12 weeks
The Faces Pain Scale (FPS)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 1, 2015

Study Record Updates

Last Update Posted (Estimate)

May 1, 2015

Last Update Submitted That Met QC Criteria

April 30, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-IBS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe