A Low FODMAPs Diet in Celiac Patients With Persistent Gastrointestinal Symptoms

Study Overview
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Brief Summary
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FODMAPS (fructose, oligosaccharides, monosaccharides, disaccharides and polyols) are characterised as fermentable but poorly absorbed carbohydrates which enter the colon and are utilised by colonic bacteria. During fasting colonic nutrients are scarce but ingesting FODMAPS causes a rapid increase in carbohydrate which can overwhelm the microbiota's ability to utilise substrate. The excess reducing equivalents will generate hydrogen or methane. The principal symptoms are diarrhoea and abdominal distension. Patients with irritable bowel syndrome appear to benefit by restricting intake, possibly because they are hypersensitive to intestinal distension. The focus of the study is to evaluate if in celiac patients with persistent abdominal symptoms and with a correct gluten free diet, a low FODMAPs diet can improve their symptoms. Moreover the study would like to observe if a dietary restriction in FODMAPs carries the risk of nutritional inadequacy.

Official Title
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The Efficacy of a Low FODMAPs (Fermentable Oligo- di- and Monosaccharides and Polyols) Diet in Celiac Patients With Persistent Gastrointestinal Symptoms

Conditions
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Celiac Disease

Intervention / Treatment
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* Dietary Supplement: Balanced low FODMAPs /gluten free diet
* Dietary Supplement: Balanced gluten free diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Celiac patients assessed through positive serology and histology functional patients according IBS Roma III criteria subjects with VAS>5 Exclusion Criteria: refractory celiac disease disaccharide intolerance (fructose an lactose breath test) abdominal surgery comorbidity patients recruited in other clinical trials positive patients at lactulose breath test (SIBO)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low FODMAPs /balanced gluten free diet<br>An expert in nutrition will give a balanced gluten free diet to patients, low in FODMAPs foods. | Dietary Supplement: Balanced low FODMAPs /gluten free diet<br> <br> |
| Active Comparator: Balanced gluten free diet<br>An expert in nutrition will give a balanced gluten free diet to patients. | Dietary Supplement: Balanced gluten free diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of VAS (psychometric response scale level continuous line between two end-points 0-10) values of globel well-being in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients in balanced gluten free diet. |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of VAS values of IBS symptoms in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet. | Evaluated IBS symptoms are: abdominal pain, bloating, satisfaction with stool consistency, epigastric pain, postprandial fullness, early satiety. | 21 days | 
| Improvement of quality of life assessed through SF-36 questionnaire (eight scale scores) in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet. |  | 21 days | 
| Improvement of psychological problems and symptoms of psychopathology through the symptom checklist 90 R (SCL 90 R) in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet. |  | 21 days | 
| Evaluation of the dietary intake in micro and macro-nutrients before and after a Low FODMAP diet or a balanced Gluten Free diet through questionnaire. |  | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FODMAPs diet, micro-macro nutrients intake, IBS (Irritable Bowel Syndrome)