Clinical trial NCT04017585: Identification of Gluten Sensitivity in Irritable Bowel Syndrome
Official title: Double Blind Randomized Clinical Trial in Subjects With Irritable Bowel Syndrome for the Identification of Gluten Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-celiac Gluten Sensitivity
Irritable Bowel Syndrome
Keywords: gluten free diet
FODMAPs
gastrointestinal symptoms
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional study
Primary purpose: DIAGNOSTIC

Brief summary: The aim of our study will be to establish in how many subjects with gastrointestinal symptoms and previous diagnosis of irritable bowel syndrome (IBS), the clinical picture is attributable to non celiac gluten sensitivity (NCGS) or fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) intolerance. For this purpose, all subjects with IBS will take a low FODMAPs diet, which implies the absence of cereals and consequently of gluten, and those presenting symptom improvement during this dietary treatment, will be exposed to a double-blind gluten or placebo challenge, to make a diagnosis of NCGS.

Detailed description: Study design:

For this study, patients with diagnosis of IBS performed by Rome IV criteria and followed as outpatients at the Clinical Nutrition Clinic of "Petrucciani" Nursing Home of Lecce (LE), Italy, will be enrolled.

At baseline, the enrolled subjects will follow a balanced normal-caloric low-FODMAP and gluten-free diet for a period of 4 weeks. At the end of the 4 weeks patients who did not experience an improvement in symptoms will be considered "non-responders" and discontinue the clinical trial. Only those subjects who had showed a significant improvement in symptoms, will be enrolled for the phase 2 of the study that includes a challenge with gluten or with placebo, as described by the Salerno criteria.

Eligibility criteria: Inclusion Criteria:

* a gluten-containing diet for at least six months before enrollment
* anti-transglutaminase antibodies (IgA and IgG) absence
* normal serum IgA levels
* prick and specific IgE tests for wheat allergy negative

Exclusion Criteria:

* celiac disease
* wheat allergy
* chronic intestinal inflammatory diseases
* psychiatric disorders
* major abdominal surgery (in particular intestinal resections)
* diabetes mellitus
* previous anaphylactic episodes
* gluten-free diet in the previous six months
* pregnant or lactating women.

Primary outcomes:
measure: Identification of FODMAP intollerance in IBS subjects
timeFrame: 4 weeks
measure: Identification of NCGS in IBS subjects who responded to low FODMAPs diet
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Michele Barone
state: BA
Study officials:
affiliation: University of Bari
name: Michele Barone
role: STUDY_DIRECTOR
References:
citation: Catassi C, Elli L, Bonaz B, Bouma G, Carroccio A, Castillejo G, Cellier C, Cristofori F, de Magistris L, Dolinsek J, Dieterich W, Francavilla R, Hadjivassiliou M, Holtmeier W, Korner U, Leffler DA, Lundin KE, Mazzarella G, Mulder CJ, Pellegrini N, Rostami K, Sanders D, Skodje GI, Schuppan D, Ullrich R, Volta U, Williams M, Zevallos VF, Zopf Y, Fasano A. Diagnosis of Non-Celiac Gluten Sensitivity (NCGS): The Salerno Experts' Criteria. Nutrients. 2015 Jun 18;7(6):4966-77. doi: 10.3390/nu7064966.
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citation: Junker Y, Zeissig S, Kim SJ, Barisani D, Wieser H, Leffler DA, Zevallos V, Libermann TA, Dillon S, Freitag TL, Kelly CP, Schuppan D. Wheat amylase trypsin inhibitors drive intestinal inflammation via activation of toll-like receptor 4. J Exp Med. 2012 Dec 17;209(13):2395-408. doi: 10.1084/jem.20102660. Epub 2012 Dec 3.
citation: Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available.
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citation: Barone M, Gemello E, Viggiani MT, Cristofori F, Renna C, Iannone A, Di Leo A, Francavilla R. Evaluation of Non-Celiac Gluten Sensitivity in Patients with Previous Diagnosis of Irritable Bowel Syndrome: A Randomized Double-Blind Placebo-Controlled Crossover Trial. Nutrients. 2020 Mar 6;12(3):705. doi: 10.3390/nu12030705.