"Gluten Friendly" Treatment in Celiac Disease (GLUFR)

August 8, 2018 updated by: Angelo Andriulli, Casa Sollievo della Sofferenza IRCCS

A Prospective, Double Blind, Placebo-controlled Trial to Evaluate Efficacy and Safety of a "Gluten Friendly" Bread in Population With Celiac Disease

A PROSPECTIVE, double blind, placebo-controlled trial

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Gluten ingestion leads to small intestinal mucosal injury in patients with celiac disease (CD), necessitating rigid, life-long exclusion of gluten from diet. Current therapies based on gluten-free dietary regimes, are also impairing social life, increased expenses for gluten free products, personal dissatisfaction and frustration. In addition, gluten-free products often have a low content of vitamins, such as vitamins B, ions such as calcium, iron, zinc and magnesium, as well of fibres. An alternative to the exclusion of gluten from diet may be the detoxification of gluten without affecting the technological performance of the flour and dough. Recently, we succeeded in developing a new and innovative method to detoxify gluten proteins from cereal grains: the modified stuff was capable to retain nutritional and technological properties of wheat proteins, and proved to be safe to celiac and gluten-sensitive patients. This innovation is usually referred to as "gluten friendly".

Objective: To establish the efficacy and safety of a prolonged exposure to the "Gluten Friendly trademark (™)" bread in patients with celiac disease.

Design: A prospective, double-blind, placebo-controlled, randomized trial to be conducted on adults with biopsy-proven CD who were being treated with a gluten-free diet (GFD) for >2 years. Before enrollment, consenting patients will have to sign an informed consent form with full details of the aims of the study, and an explanation of the experimental procedures of the study. At the baseline evaluation (t 0 ), patients will undergo a clinical examination, an upper gastrointestinal endoscopy for the histologic evaluation of the duodenal mucosa, and a blood drawing for routine chemistry and anti-transglutaminase (ATGA) and anti-endomysium (EMA) antibodies checking. Eligible to be enrolled into the study will be patients with undetectable ATGA and EMA antibodies. They will be randomly assigned to one of three experimental regimens:

  1. the control arm: patients will maintain a commercially available GFD and receive bread containing 3 gr of cornstarch daily for 12 weeks; these patients will serve as controls (Group A)
  2. the innovative arm 1: patients will be have to continue the GFD supplemented with 3 gr of "gluten friendly"™ bread daily for 12 weeks (Group B)
  3. the innovative arm 2: patients will be have to continue the GFD supplemented with 6 gr of "gluten friendly"™ bread daily for 12 weeks (group C).

All patients will be provided with a diary card to monitor their adherence to the assigned treatments and to register their acceptance of the experimental breads. Either patients and attending physicians will maintain blindness about the treatment assignment throughout t the study period.

At the end of the 2nd and 4th treatment week, patients will be monitored for ATGA and EMA antibodies, and those with positive results will undergo a repeat endoscopy for checking the integrity of the duodenal mucosa: in the event of any deterioration of histology, patients will patients will be considered as treatment failures. Patients with negative serology will be kept on treatment for the scheduled 12 weeks. At 12th week, patients will have to return for a clinical examination, a repeat blood drawing for ATGA, anti-EMA, anti-gliadin (AGA both IgG and IgA) antibodies checking, immunoglobulin G (IgG), immunoglobulin A (IgA), routine chemistry, complete hematology work up including serum iron, phosphorus, folate, and vitamin D3 measurements. In addition, a new, repeat endoscopy will be scheduled for all enrolled patients with the intent to acquire information on the histologic status of the duodenal mucosa, the the principal outcome of this investigation. After the completion of the 12 weeks study period, all patients will be invited to enter in an open study in which the addition of the "Gluten Friendly ™" bread to their GFD diet will be administered for a very long period of time, likely 6 or 12 months. This section of the study will be run on a voluntary basis and will serve to gain information about safety of the modified gluten in the long run.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • FG
      • San Giovanni Rotondo, FG, Italy, 71013
        • Angelo Andriulli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • celiac patients with positive antitransglutaminase and histology compatible with celiac disease

Exclusion Criteria:

  • positive antitransglutaminase at enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Arm A comparator
Arm A: patients will maintain a commercially available gluten free diet and receive bread containing 3 gr of cornstarch daily for 12 weeks; these patients will serve as controls.
Other: Gluten free bread
patients will receive bread containing 3 g of cornstarch daily for 12 weeks; these patients will serve as controls
EXPERIMENTAL: Arm B
Dietary supplement: patients will be have to continue the gluten free diet supplemented with 3 gr of "gluten friendly" bread daily for 12 weeks.
Other: Gluten free bread
patients will receive bread containing 3 g of cornstarch daily for 12 weeks; these patients will serve as controls
Dietary supplement: Gluten friendly bread 3g/day
patients will have to continue the GFD supplemented with 3 gr of "gluten friendly" bread daily for 12 weeks
EXPERIMENTAL: Arm C
Dietary supplement: patients will be have to continue the gluten free diet supplemented with 6 gr of "gluten friendly" bread daily for 12 weeks
Dietary supplement: Gluten friendly bread 6g/day
patients will have to continue the GFD supplemented with 6 gr of "gluten friendly" bread daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measure of small bowel mucosal density and evaluation of the serologic markers of celiac disease
Time Frame: Three months after of treatment
Endoscopy evaluation of duodenum and determination of anti-tTG2-IgA, EMA and AGA antibodies levels
Three months after of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Casa Sollievo della Sofferenza IRCCS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Foggia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCT64/CE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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