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

Not Applicable

Completed

• Conditions: Gluten Sensitivity; Irritable Bowel Syndrome

• Registration Number: NCT03638544
• Lead Sponsor: University of Bari

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2017-12-31
• Study First Submitted: 2018-07-11
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-15
• Last Update Submitted: 2018-08-15
• Study First Posted: 2018-08-20
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change of IBS severity measured by Visual analogue scale (VAS)	Two weeks of each different diet interspersed by one week of wash out. The scale will be completed ones a day.	Change of severity of IBS symptoms measured by Visual analogue scale (VAS) between reduced gluten content diet and standard gluten content diet. The 0-10 mm VAS scale (0 no pain, 10 worst possible pain) included a horizontal color gradient (green-red).
Change in Severity of IBS symptoms measured by Irritable Bowel Syndrome-Severity Score (IBS-SS)	two weeks of each different diet interspersed by one week of wash out. The questionnaire will be completed ones a week.	Change in IBS Severity Score (IBS-SS) between reduced gluten content diet and standard gluten content diet. Mild, moderate and severe cases were indicated by scores of 75 to 175, 175 to 300 and "300 respectively. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300, and \>300, respectively.

Secondary Outcome Measures

Name	Time	Method
Change of Quality of life scores	two weeks of each different diet interspersed by one week of wash out. The scale will be completed ones a week.	Irritable Bowel Syndrome Quality of Life (IBS-QoL) between reduced gluten content diet and standard gluten content diet.