"Gluten Friendly" Treatment in Celiac Disease

NCT03137862 | Completed

• 1 other identifier: NCT64/CE
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

A PROSPECTIVE, double blind, placebo-controlled trial

Conditions

Food Intolerance; Celiac Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Three months after of treatment

Study Arms (3)

Arm A comparator

PLACEBO 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

Arm B

EXPERIMENTAL

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; Dietary Supplement: Gluten friendly bread 3g/day

Arm C

EXPERIMENTAL

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

Interventions

Gluten free bread OTHER

patients will receive bread containing 3 g of cornstarch daily for 12 weeks; these patients will serve as controls

Arm A comparator; Arm B

Gluten friendly bread 3g/day DIETARY_SUPPLEMENT

patients will have to continue the GFD supplemented with 3 gr of "gluten friendly" bread daily for 12 weeks

Arm B

Gluten friendly bread 6g/day DIETARY_SUPPLEMENT

patients will have to continue the GFD supplemented with 6 gr of "gluten friendly" bread daily for 12 weeks

Arm C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• positive antitransglutaminase at enrollment

Sponsors & Collaborators

• Casa Sollievo della Sofferenza IRCCS: lead
• University of Foggia: collaborator

Study Sites (1)

Angelo Andriulli

San Giovanni Rotondo, FG, 71013, Italy

Location

Related Publications (1)

• 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.

  PMID: 35029612 DERIVED

MeSH Terms

Conditions

Food Intolerance; Celiac Disease

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastroenterology and Digestive Endoscopy CSDSofferenza

Model Details: double blind prospective study

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: May 3, 2017
• Study Start: March 20, 2017
• Primary Completion: April 2, 2017
• Study Completion: January 15, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)