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

NCT03638544 | Completed

• 1 other identifier: PROALIFUN
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Irritable Bowel Syndrome; Gluten Sensitivity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Reduced Gluten-Normal Gluten

ACTIVE COMPARATOR

Dietary Supplement: Reduced gluten bread and Pasta compared o normal gluten bread and Pasta

Normal Gluten-Reduced Gluten

ACTIVE COMPARATOR

Dietary Supplement: Reduced gluten bread and Pasta compared o normal gluten bread and Pasta

Interventions

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.

Normal Gluten-Reduced Gluten; Reduced Gluten-Normal Gluten

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bari: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome; Celiac Disease

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: Double blind placebo controlled Gluten Sensitivity

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 20, 2018
• Study Start: January 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2017
• Last Updated: August 20, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share