An Open-label Randomised Pilot Trial on Safety of Wheat Variety C273 in Patients with Adult Celiac Disease

Overview

Journal Therap Adv Gastroenterol

Publisher Sage Publications

Specialty Gastroenterology

Date 2020 Sep 11

PMID 32913443

Authors

Jasmine Grover

Parveen Chhuneja

Vandana Midha

Arshdeep Singh

Ramit Mahajan

Varun Mehta

Ramneek Verma

Ekta Bansal

Dipak Deka

Namita Bansal

Neena Sood

Vikram Narang

Ajit Sood

Affiliations

Soon will be listed here.

Abstract

Background: The only effective treatment for celiac disease (CeD) is gluten free diet (GFD). However, GFD is restrictive and efforts are being made to explore alternative therapies including safer wheat varieties. Wheat variety C273 has been previously identified to have reduced load of intact T-cell stimulatory epitopes and analysis.

Methods: Adult patients diagnosed with CeD and recovered on GFD were included in the study. Patients were randomised into two groups in a 2:1 ratio. Patients in group I had graded introduction of C273 wheat in diet, maintained for 24 weeks; in Group II, wheat was restricted with continuation of GFD. Clinical symptoms, serology [anti-tissue transglutaminase (anti-tTG), anti-endomysial antibody (anti-EMA)], circulating inflammatory biomarkers [intestinal fatty-acid binding protein (I-FABP), plasma citrulline, interferon-γ (IFN-γ)] and histology were evaluated periodically. Final evaluation was performed at week 28.

Results: A total of 15 patients were enrolled (Group I: = 10, Group II: = 5). All patients except two in Group I remained compliant. None of the remaining eight patients in group I developed symptoms. No significant changes in serology (anti-tTG, anti-EMA) and histology were observed between the two groups at 28 weeks ( > 0.05). Significant changes in plasma citrulline(29.87 ± 8.98 36.58 ± 3.09, = 0.049) and IFN-γ (44.56 ± 9.74 33.50 ± 3.68; = 0.031) were observed in Group I.

Conclusion: Consumption of C273 wheat did not result in development of symptoms or evident changes in serology and histology at 28 weeks. However, variations in circulating inflammatory markers were noted. Larger randomised trials are needed to corroborate these findings.

Clinical Trials Registry-india: CTRI/2018/06/014521.

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