Reduced Content of Gluten Diet on Patients With Irritable Bowel Syndrome (Pro.Ali.Fun.) (PROALIFUN)

University of Bari

Status: Completed

Conditions: Irritable Bowel Syndrome; Gluten Sensitivity

Treatments: Dietary Supplement: Reduced gluten bread and Pasta compared o normal gluten bread and Pasta

Study type: Interventional

Funder types: Other

Identifiers

NCT03638544

PROALIFUN

Details and patient eligibility

About

This study aim to manufacture bread and pasta with an reduced content of gluten and to assess the impact of reducing the daily intake of gluten by 50% in irritable bowel syndrome (IBS) patients. Fungal proteases and selected sourdough lactic acid bacteria will be used for making wheat bread and pasta with a reduced content of gluten (RG) (-50% of traditional products). From a technological point of view, the chemical, structural and sensory features of the RG products approached those of the bread and pasta made with normal level of gluten. The efficacy and safety of new products will be compared to traditional bread and pasta by using a double blind randomized, crossover-controlled trial in IBS patients with persistent gastrointestinal symptoms. Patients will follow two weeks of a GFD diet containing RG bread and pasta and two weeks of GFD diet containing Normal Gluten bread and pasta Symptoms severity will be assessed by Irritable Bowel Syndrome Severity Score (IBS-SS), Visual Analogue Scale (VAS), Hospital Anxiety and Depression Scale (HADS) and Irritable Bowel Syndrome Quality of Life (IBS-QoL).

Enrollment: 20 patients

Sex

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age above 18 years;
2. having bowel symptoms (altered bowel habit, lower abdominal pain, bloating, or distention suggestive of IBS), as determined by Rome III criteria.
3. Previous exclusion of CD and wheat allergy

Exclusion criteria

1. previous GI malignancy and/or surgery;

2. clinically significant cardiovascular, respiratory, endocrine, renal, hematologic or hepatic disease.

3. other clinically significant medical condition; pregnancy or lactation; alcohol abuse; drug addiction; severe neurologic or psychiatric disorders; long-term use of corticosteroids or anti-inflammatory drugs

4. participation in another clinical trial within 6 months before the onset of this trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Reduced Gluten-Normal Gluten

Active Comparator group

Treatment:

Dietary Supplement: Reduced gluten bread and Pasta compared o normal gluten bread and Pasta

Normal Gluten-Reduced Gluten

Active Comparator group

Treatment:

Dietary Supplement: Reduced gluten bread and Pasta compared o normal gluten bread and Pasta