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

Irritable Bowel Syndrome Clinical Trial

— PROALIFUN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638544
• Other study ID #: PROALIFUN
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2018
• Source: University of Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gluten Sensitivity
• Irritable Bowel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Bari

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.