A Low FODMAPs Diet in Celiac Patients With Persistent Gastrointestinal Symptoms

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Unknown

Conditions: Celiac Disease

Treatments: Dietary Supplement: Balanced gluten free diet; Dietary Supplement: Balanced low FODMAPs /gluten free diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02946827

2016/464

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

Low FODMAPs /balanced gluten free diet

Experimental group

Description:

An expert in nutrition will give a balanced gluten free diet to patients, low in FODMAPs foods.

Treatment:

Dietary Supplement: Balanced low FODMAPs /gluten free diet

Balanced gluten free diet

Active Comparator group

Description:

An expert in nutrition will give a balanced gluten free diet to patients.

Treatment:

Dietary Supplement: Balanced gluten free diet