Celiac Disease
Conditions
Keywords
FODMAPs diet, micro-macro nutrients intake, IBS (Irritable Bowel Syndrome)
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTBalanced low FODMAPs /gluten free diet
DIETARY_SUPPLEMENTBalanced gluten free diet
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 21 days | Evaluated IBS symptoms are: abdominal pain, bloating, satisfaction with stool consistency, epigastric pain, postprandial fullness, early satiety. |
| 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 | — |
Countries
Italy
Contacts
Primary ContactLeda Roncoroni, BS PhD
Backup ContactLeda Roncoroni
Outcome results
None listed