Clinical trial NCT02946827: A Low FODMAPs Diet in Celiac Patients With Persistent Gastrointestinal Symptoms
Official title: The Efficacy of a Low FODMAPs (Fermentable Oligo- di- and Monosaccharides and Polyols) Diet in Celiac Patients With Persistent Gastrointestinal Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Celiac Disease
Keywords: FODMAPs diet
micro-macro nutrients intake
IBS (Irritable Bowel Syndrome)
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 21 days
Secondary outcomes:
measure: 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.
timeFrame: 21 days
measure: 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.
timeFrame: 21 days
measure: 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.
timeFrame: 21 days
measure: 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.
timeFrame: 21 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: University of Milan
Study officials:
References: