Identification of Gluten Sensitivity in Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— IBS-NCGS  

Official title:

Double Blind Randomized Clinical Trial in Subjects With Irritable Bowel Syndrome for the Identification of Gluten Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017585
• Other study ID #: Policlinic Hospital 5, Bari
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: December 2019
• Source: University of Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Irritable Bowel Syndrome
• Non-celiac Gluten Sensitivity
• Syndrome

Intervention

Dietary Supplement:
• diet containing gluten
gluten will be added for 7 days to the low FODMAP/gluten free diet diet. After 1 week of wash-out, patients will switch (cross-over) to placebo for another 7 days
• Diet containing placebo
Placebo will be added for 7 days to the low FODMAP/gluten free diet diet. After 1 week of wash-out, patients will switch (cross-over) to gluten for another 7 days

Locations

Country	Name	City	State
Italy	Michele Barone	Bari	BA

Sponsors (1)

Lead Sponsor	Collaborator
University of Bari

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Calasso M, Francavilla R, Cristofori F, De Angelis M, Gobbetti M. New Protocol for Production of Reduced-Gluten Wheat Bread and Pasta and Clinical Effect in Patients with Irritable Bowel Syndrome: A randomised, Double-Blind, Cross-Over Study. Nutrients. 2 — View 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. — View Citation

Catassi C, Alaedini A, Bojarski C, Bonaz B, Bouma G, Carroccio A, Castillejo G, De Magistris L, Dieterich W, Di Liberto D, Elli L, Fasano A, Hadjivassiliou M, Kurien M, Lionetti E, Mulder CJ, Rostami K, Sapone A, Scherf K, Schuppan D, Trott N, Volta U, Ze — View 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, Körner U, Leffler DA, Lundin KE, Mazzarella G, Mulder CJ, Pellegrini N, Rostami — View Citation

Drossman DA. Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features and Rome IV. Gastroenterology. 2016 Feb 19. pii: S0016-5085(16)00223-7. doi: 10.1053/j.gastro.2016.02.032. [Epub ahead of print] — View Citation

Jones AL. The Gluten-Free Diet: Fad or Necessity? Diabetes Spectr. 2017 May;30(2):118-123. doi: 10.2337/ds16-0022. — View 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 — View Citation

Van den Houte K, Carbone F, Pannemans J, Corsetti M, Fischler B, Piessevaux H, Tack J. Prevalence and impact of self-reported irritable bowel symptoms in the general population. United European Gastroenterol J. 2019 Mar;7(2):307-315. doi: 10.1177/20506406 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of FODMAP intollerance in IBS subjects	To evaluate the FODMAP intolerance, the response to a low FODMAP diet will be assessed by a visual analogue scale (VAS) before and after the dietary challenge. The VAS scale consists in is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptoms, pain, subjective feeling of well-being/malaise) orientated from the left (worst) to the right (best) The patient is invited to indicate a position (a point) along the line.	4 weeks
Primary	Identification of NCGS in IBS subjects who responded to low FODMAPs diet	To evaluate the NCGS, the response to the gluten challenge will be assessed by a visual analogue scale (VAS) before and after the dietary challenge. The VAS scale consists in is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptoms, pain, subjective feeling of well-being/malaise) orientated from the left (worst) to the right (best) The patient is invited to indicate a position (a point) along the line.	3 weeks