NCT03638544: PROALIFUN

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

Completed NA Last updated 20 August 2018

What this trial tests

NA trial testing Reduced gluten bread and Pasta compared o normal gluten bread and Pasta in Irritable Bowel Syndrome in 20 participants. Completed in 31 December 2017.

Timeline

1 January 2014

Primary endpoint
31 December 2016

31 December 2017

Quick facts

Lead sponsor	University of Bari
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	20
Start date	1 January 2014
Primary completion	31 December 2016
Estimated completion	31 December 2017

Drugs / interventions tested

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

Conditions studied

• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →
• Gluten Sensitivity — all drugs for Gluten Sensitivity →

Sponsor

University of Bari

Who can join

18 and older, any sex, with Irritable Bowel Syndrome or Gluten Sensitivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. New Protocol for Production of Reduced-Gluten Wheat Bread and Pasta and Clinical Effect in Patients with Irritable Bowel Syndrome: A randomised, Double-Blind, Cross-Over Study.
   Calasso M, Francavilla R, Cristofori F, De Angelis M, et al · · 2018 · cited 14× · PMID 30513824 · DOI 10.3390/nu10121873