Clinical trial NCT03638544: Reduced Content of Gluten Diet on Patients With Irritable Bowel Syndrome (Pro.Ali.Fun.)
Official title: Effect of Wheat Bread and Pasta With Reduced Content of Gluten on Patients With Irritable Bowel Syndrome: Randomized Controlled Cross Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Gluten Sensitivity
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 20
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double blind placebo controlled Gluten Sensitivity
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

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Primary outcomes:
measure: Change in Severity of IBS symptoms measured by Irritable Bowel Syndrome-Severity Score (IBS-SS)
timeFrame: two weeks of each different diet interspersed by one week of wash out. The questionnaire will be completed ones a week.
measure: Change of IBS severity measured by Visual analogue scale (VAS)
timeFrame: Two weeks of each different diet interspersed by one week of wash out. The scale will be completed ones a day.
Secondary outcomes:
measure: Change of Quality of life scores
timeFrame: two weeks of each different diet interspersed by one week of wash out. The scale will be completed ones a week.
Other outcomes:
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