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Completed

NCT Number: NCT04017585

Identification of Gluten Sensitivity in Irritable Bowel Syndrome

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.

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Key information

Conditions

Non-celiac Gluten Sensitivity Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michele Barone

Bari, BA, 70124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

diet containing gluten

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. Identification of FODMAP intollerance in IBS subjects

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

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

Acronym: IBS-NCGS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2019
Registry last updated
Dec 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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