Irritable Bowel Syndrome, Non-celiac Gluten Sensitivity
Conditions
Keywords
gluten free diet, FODMAPs, gastrointestinal symptoms
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.
Interventions
DIETARY_SUPPLEMENTdiet 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
DIETARY_SUPPLEMENTDiet 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
Sponsors
University of Bari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Interventional study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Italy
Outcome results
None listed