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

NCT03638544 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-08-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Bari

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2016-12-31
Completion
2017-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03638544 on ClinicalTrials.gov