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

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).

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Key information

Conditions

Irritable Bowel Syndrome Celiac Disease Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Gluten Sensitivity Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

previous GI malignancy and/or surgery;
clinically significant cardiovascular, respiratory, endocrine, renal, hematologic or hepatic disease.
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
participation in another clinical trial within 6 months before the onset of this trial.

Treatment and study plan

Reduced gluten bread and Pasta compared o normal gluten bread and Pasta

Dietary Supplement

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.

Primary outcomes

Change in Severity of IBS symptoms measured by Irritable Bowel Syndrome-Severity Score (IBS-SS)

Time frame: 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.
Change of IBS severity measured by Visual analogue scale (VAS)

Time frame: 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).

Secondary outcomes

Change of Quality of life scores

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

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

Acronym: PROALIFUN

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2017
First posted: Aug 20, 2018
Registry last updated: Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed