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Irritable Bowel Syndrome and the Identification of Wheat or Gluten Sensitivity (IBS-NCGS)

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ClinicalTrials.gov Identifier: NCT04017585
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Michele Barone, University of Bari

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: Placebo Not Applicable

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 30 days. At the end of the 30 days 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Interventional 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 Wheat or Gluten Sensitivity
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: patients with IBS treated with gluten
patients receiving flour with gluten (nocebo)
Dietary Supplement: diet containing gluten
gluten-free flour (placebo) will be added for 5 days to the low FODMAP diet. After 1 week of wash-out, patients will switch to flour with gluten (nocebo) for another 5 days
Other Name: gluten-free diet

Placebo Comparator: patients with IBS treated with placebo
patients receiving gluten-free flour (placebo)
Dietary Supplement: Placebo
Placebo




Primary Outcome Measures :
  1. Identification of FODMAP intollerance in IBS subjects [ Time Frame: 1 months ]
    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 [ Time Frame: 17 days ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017585


Contacts
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Contact: Michele Barone, Prof 3477157666 ext 0039 michele.barone@uniba.it

Locations
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Italy
Michele Barone Recruiting
Bari, BA, Italy, 70124
Contact: Michele Barone    3477157666    michele.barone@uniba.it   
Sponsors and Collaborators
University of Bari
Investigators
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Study Director: Michele Barone University of Bari

Publications of Results:

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Responsible Party: Michele Barone, Professor, University of Bari
ClinicalTrials.gov Identifier: NCT04017585     History of Changes
Other Study ID Numbers: Policlinic Hospital 5, Bari
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michele Barone, University of Bari:
gluten free diet
FODMAPs
gastrointestinal symptoms

Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Hypersensitivity
Syndrome
Disease
Pathologic Processes
Immune System Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases