"Gluten Friendly" Treatment in Celiac Disease (GLUFR)
Primary Purpose
Food Intolerance, Celiac Disease
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Gluten free bread
Gluten friendly bread 3g/day
Gluten friendly bread 6g/day
Sponsored by
About this trial
This is an interventional other trial for Food Intolerance
Eligibility Criteria
Inclusion Criteria:
- celiac patients with positive antitransglutaminase and histology compatible with celiac disease
Exclusion Criteria:
- positive antitransglutaminase at enrollment
Sites / Locations
- Angelo Andriulli
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Arm A comparator
Arm B
Arm C
Arm Description
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.
Dietary supplement: patients will be have to continue the gluten free diet supplemented with 3 gr of "gluten friendly" bread daily for 12 weeks.
Dietary supplement: patients will be have to continue the gluten free diet supplemented with 6 gr of "gluten friendly" bread daily for 12 weeks
Outcomes
Primary Outcome Measures
Measure of small bowel mucosal density and evaluation of the serologic markers of celiac disease
Endoscopy evaluation of duodenum and determination of anti-tTG2-IgA, EMA and AGA antibodies levels
Secondary Outcome Measures
Full Information
NCT ID
NCT03137862
First Posted
April 10, 2017
Last Updated
August 8, 2018
Sponsor
Casa Sollievo della Sofferenza IRCCS
Collaborators
University of Foggia
1. Study Identification
Unique Protocol Identification Number
NCT03137862
Brief Title
"Gluten Friendly" Treatment in Celiac Disease
Acronym
GLUFR
Official Title
A Prospective, Double Blind, Placebo-controlled Trial to Evaluate Efficacy and Safety of a "Gluten Friendly" Bread in Population With Celiac Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
April 2, 2017 (Actual)
Study Completion Date
January 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Casa Sollievo della Sofferenza IRCCS
Collaborators
University of Foggia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A PROSPECTIVE, double blind, placebo-controlled trial
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:
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)
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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Intolerance, Celiac Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double blind prospective study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A comparator
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Dietary supplement: patients will be have to continue the gluten free diet supplemented with 3 gr of "gluten friendly" bread daily for 12 weeks.
Arm Title
Arm C
Arm Type
Experimental
Arm Description
Dietary supplement: patients will be have to continue the gluten free diet supplemented with 6 gr of "gluten friendly" bread daily for 12 weeks
Intervention Type
Other
Intervention Name(s)
Gluten free bread
Intervention Description
patients will receive bread containing 3 g of cornstarch daily for 12 weeks; these patients will serve as controls
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten friendly bread 3g/day
Intervention Description
patients will have to continue the GFD supplemented with 3 gr of "gluten friendly" bread daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten friendly bread 6g/day
Intervention Description
patients will have to continue the GFD supplemented with 6 gr of "gluten friendly" bread daily for 12 weeks
Primary Outcome Measure Information:
Title
Measure of small bowel mucosal density and evaluation of the serologic markers of celiac disease
Description
Endoscopy evaluation of duodenum and determination of anti-tTG2-IgA, EMA and AGA antibodies levels
Time Frame
Three months after of treatment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
celiac patients with positive antitransglutaminase and histology compatible with celiac disease
Exclusion Criteria:
positive antitransglutaminase at enrollment
Facility Information:
Facility Name
Angelo Andriulli
City
San Giovanni Rotondo
State/Province
FG
ZIP/Postal Code
71013
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35029612
Citation
Andriulli A, Bevilacqua A, Palmieri O, Latiano A, Fontana R, Gioffreda D, Castellana S, Mazza T, Panza A, Menzaghi C, Grandone E, di Mauro L, Decina I, Tricarico M, Musaico D, Maki M, Isola J, Popp A, Taavela J, Petruzzi L, Sinigaglia M, Rosaria Corbo M, Lamacchia C. Healthy and pro-inflammatory gut ecology plays a crucial role in the digestion and tolerance of a novel Gluten Friendly bread in celiac subjects: a randomized, double blind, placebo control in vivo study. Food Funct. 2022 Feb 7;13(3):1299-1315. doi: 10.1039/d1fo00490e.
Results Reference
derived
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"Gluten Friendly" Treatment in Celiac Disease
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