Brief Summary

In the last two decades, a series of epidemiological studies have shown a particular increase in Coeliac Disease (CD), a life-long intolerance to gluten proteins (the seed storage proteins) present in most cereals (wheat, barley and rye) both in the United States and Europe, and in developing countries. In these subjects, the consumption of cereals containing gluten causes a chronic inflammatory process leading to lesions in the small intestine and a dysfunction in nutrient absorption.The only current treatment for CD is a strict lifelong gluten-free diet. In most cases (some people do not respond) this dietary regimen guarantees the full recovery of small intestine architecture and functions, though for many patients the gluten-free diet is highly restrictive, especially for social events and during travelling. In addition, this dietary therapy has often low content of vitamins and ions, such as vitamins B and calcium, iron, zinc and magnesium, as well as fibre. Furthermore, one of the major risks is to develop obesity and diseases related to metabolic syndrome. Recently a new and innovative detoxification method has been developed with the purpose to overcome the disadvantages of the prior methods. The method is based on the application of microwave energy for few seconds to hydrated wheat kernels; the treatment induces modifications to endosperm components which dramatically reduce the immunogenicity of the most common epitopes involved in coeliac disease, without compromising the technological properties necessary to process flour into bread, pasta and other baked goods. The method is based on the analysis of recent studies that have reported, when high temperatures are applied to the caryopsis of wheat, the protein polymers present in the pasta produced with these "baked grain" present a size distribution pattern that is not observed in pasta during the drying cycles. The researchers Lamacchia and others explained this phenomenon on the basis of the fact that in the caryopsis of wheat, gluten is not yet formed and gluten proteins are deposited in different protein bodies.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.7 years study duration

Study Start

First participant enrolled

February 1, 2016

Completed

1.3 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed

8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2018

Completed

2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2021

Completed

Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

May 22, 2017

Last Update Submit

September 28, 2021

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

The cellular and molecular basis for modulation of immune function by GLUTEN FRIENDLY BREAD
Blood samples will be processed and analyzed for inflammatory/immune biomarkers (trans-glutaminase IgA and IgG, cytokines INF-Ɣ, IL-6, IL-8, IL-10, TNF-α and C-reactive protein). activation markers, expression of toll like receptors.
Change from baseline at 14 days

Secondary Outcomes (1)

The modulation of the gut microbiota by gluten friendly bread
Change from baseline at 14 days

Other Outcomes (3)

Digestive symptoms
Change from baseline at 14 days
Microbiota activity (intestinal gas production)
Change from baseline at 14 days
Intestinal gut permeability
Change from baseline at 14 days

Study Arms (5)

1.5g low gluten friendly bread

ACTIVE COMPARATOR

1.5g low gluten friendly bread as15g bun/day to be consumed as 250 ml beverages at breakfast for 14 days