Ignite Creation Date:
2024-05-06 @ 4:02 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02431585
Status:
UNKNOWN
Last Update Posted:
2015-05-01
First Post:
2014-10-17
Brief Title:
Prevalence of Gluten Sensitivity in Irritable Bowel Syndrome The First Study in Paediatrics
Sponsor:
University of Bari
Organization:
University of Bari
Study Overview
Official Title:
Prevalence of Gluten Sensitivity in Irritable Bowel Syndrome The First Study in Paediatrics GS-IBS
Status:
UNKNOWN
Status Verified Date:
2015-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GS-IBS
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 populationThe 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 andor 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 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 andor 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
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 andor 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-SS75 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
Diagnosis of coeliac disease and wheat allergy will be excluded by the negativity of TTG-IgA andor 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-SS75 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None