IBS-NCGS: Identification of Gluten Sensitivity in Irritable Bowel Syndrome

• Sponsor: University of Bari (Other)
• Overall Status: Completed
• CT.gov ID: NCT04017585
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.7
• Patients Per Site Per Month: 5.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-celiac Gluten Sensitivity; Irritable Bowel Syndrome	Dietary Supplement: diet containing gluten; Dietary Supplement: Diet containing placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Interventional studyInterventional study
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: Double Blind Randomized Clinical Trial in Subjects With Irritable Bowel Syndrome for the Identification of Gluten Sensitivity
• Actual Study Start Date: Apr 8, 2019
• Actual Primary Completion Date: Sep 30, 2019
• Actual Study Completion Date: Oct 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: patients with IBS treated with gluten patients receiving gluten	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
Placebo Comparator: patients with IBS treated with placebo patients receiving placebo	Dietary Supplement: 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

Outcome Measures

Primary Outcome Measures

1. Identification of FODMAP intollerance in IBS subjects [4 weeks]

   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.

2. Identification of NCGS in IBS subjects who responded to low FODMAPs diet [3 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michele Barone	Bari	BA	Italy	70124

Sponsors and Collaborators

• University of Bari

Investigators

• Study Director: Michele Barone, University of Bari

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michele Barone, Professor, University of Bari
• ClinicalTrials.gov Identifier: NCT04017585
• Other Study ID Numbers: Policlinic Hospital 5, Bari
• First Posted: Jul 12, 2019
• Last Update Posted: Dec 27, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michele Barone, Professor, University of Bari: gluten free diet; FODMAPs; gastrointestinal symptoms
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Hypersensitivity; Syndrome

Study Results

No Results Posted as of Dec 27, 2019