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

Effect of Wheat Bread and Pasta With Reduced Content of Gluten on Patients With Irritable Bowel Syndrome: Randomized Controlled Cross Over Study

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).

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome; Gluten Sensitivity
• Intervention / Treatment: Dietary supplement: Reduced gluten bread and Pasta compared o normal gluten bread and Pasta

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Reduced Gluten-Normal Gluten	Dietary supplement: Reduced gluten bread and Pasta compared o normal gluten bread and Pasta; Pasta with low gluten (50% of the normal) content achieved by optimization of techological parameters such as dough yield, time of fermentation and concentration of fungal proteases The gluten reduction is obtained without any other intervention of wheat breeding or the endogenous proteolytic enzymes of flours.
ACTIVE_COMPARATOR: Normal Gluten-Reduced Gluten	Dietary supplement: Reduced gluten bread and Pasta compared o normal gluten bread and Pasta; Pasta with low gluten (50% of the normal) content achieved by optimization of techological parameters such as dough yield, time of fermentation and concentration of fungal proteases The gluten reduction is obtained without any other intervention of wheat breeding or the endogenous proteolytic enzymes of flours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Severity of IBS symptoms measured by Irritable Bowel Syndrome-Severity Score (IBS-SS)	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.	two weeks of each different diet interspersed by one week of wash out. The questionnaire will be completed ones a week.
Change of IBS severity measured by Visual analogue scale (VAS)	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).	Two weeks of each different diet interspersed by one week of wash out. The scale will be completed ones a day.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Bari

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (ACTUAL): August 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: PROALIFUN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No